<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028415</url>
  </required_header>
  <id_info>
    <org_study_id>000226</org_study_id>
    <secondary_id>G150153</secondary_id>
    <nct_id>NCT03028415</nct_id>
  </id_info>
  <brief_title>AMPLEX Ankle Fusion and Hindfoot</brief_title>
  <official_title>A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in&#xD;
      a population indicated for single, double, or triple hindfoot arthrodesis or ankle&#xD;
      arthrodesis surgery with supplemental graft material.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">July 9, 2020</completion_date>
  <primary_completion_date type="Actual">January 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint</measure>
    <time_frame>At week 52</time_frame>
    <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success</measure>
    <time_frame>At week 52</time_frame>
    <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving CT Radiographic Fusion Success</measure>
    <time_frame>At week 12</time_frame>
    <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving CT Radiographic Fusion Success</measure>
    <time_frame>At week 24</time_frame>
    <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</measure>
    <time_frame>Baseline, and at week 12</time_frame>
    <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</measure>
    <time_frame>Baseline, and at week 24</time_frame>
    <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</measure>
    <time_frame>Baseline, and at week 52</time_frame>
    <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</measure>
    <time_frame>At week 2</time_frame>
    <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</measure>
    <time_frame>At week 6</time_frame>
    <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</measure>
    <time_frame>At week 12</time_frame>
    <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</measure>
    <time_frame>At week 24</time_frame>
    <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</measure>
    <time_frame>At week 52</time_frame>
    <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FAAM-ADL</measure>
    <time_frame>Baseline, and at week 12</time_frame>
    <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FAAM-ADL</measure>
    <time_frame>Baseline, and at week 24</time_frame>
    <description>Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FAAM-ADL</measure>
    <time_frame>Baseline, and at week 52</time_frame>
    <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Performance Composite (SPC) Endpoint</measure>
    <time_frame>At week 12</time_frame>
    <description>Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Performance Composite (SPC) Endpoint</measure>
    <time_frame>At week 24</time_frame>
    <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-12 (SF-12)</measure>
    <time_frame>Baseline, and at week 24</time_frame>
    <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Short Form-12 (SF-12)</measure>
    <time_frame>Baseline, and at week 52</time_frame>
    <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Arthrodesis Surgery Involving the Hindfoot or Ankle</condition>
  <arm_group>
    <arm_group_label>AMPLEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Autogenous Bone Graft (ABG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AMPLEX</intervention_name>
    <description>A bone graft substitute</description>
    <arm_group_label>AMPLEX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autogenous Bone Graft (ABG)</intervention_name>
    <description>Control material administered by surgical implant</description>
    <arm_group_label>Autogenous Bone Graft (ABG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Indicated for ankle or hindfoot arthrodesis and require one of the following&#xD;
             arthrodesis procedures:&#xD;
&#xD;
        Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double&#xD;
        hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar,&#xD;
        talonavicular and calcaneocuboid joints)&#xD;
&#xD;
          -  Presents with pain on weight-bearing of at least 40 mm on a 100 mm VAS at the area&#xD;
             indicated for arthrodesis&#xD;
&#xD;
          -  Presents with at least one comorbid risk factors that warrant the use of supplemental&#xD;
             autogenous bone or allograft:&#xD;
&#xD;
        Radiographic evidence of bone defect, deficit, subsidence or subchondral cyst; More than&#xD;
        one joint to be fused; Involvement of other adjacent or nonadjacent joints; Large surface&#xD;
        area; Intra-articular or extra-articular deformity; Post-traumatic arthritis; Diagnosis of&#xD;
        osteoporosis&#xD;
&#xD;
          -  The Investigator determines if the joint space(s) can be adequately filled with graft&#xD;
             material (AMPLEX or ABG) according to the following parameters:&#xD;
&#xD;
        Single hindfoot joint fusion: up to 5 cm^3; Double or triple hindfoot fusion: each&#xD;
        individual joint up to 5 cm^3, but overall, not more than 10 cm3 for the full complement of&#xD;
        joints; Ankle fusion: up to 10 cm^3&#xD;
&#xD;
          -  Each fused joint can be rigidly stabilized with with at least 1 and no more than 3&#xD;
             screws across the fusion plane. (Supplemental pins and staples may be used, as well as&#xD;
             supplemental screws and plates external to the fusion site(s))&#xD;
&#xD;
          -  Willing and able to comply with all study requirements including all postoperative&#xD;
             clinical and radiographic evaluations&#xD;
&#xD;
          -  For women of childbearing potential (not post-menopausal for 12 months or surgically&#xD;
             sterile), a urine pregnancy test with a negative result must be obtained at screening&#xD;
             and within 24 hours prior to procedure. These trial participants must commit to&#xD;
             adequate birth control (e.g., oral contraceptive, two methods of barrier birth&#xD;
             control, or abstinence) through the 78 week follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone deficit requiring a structural graft&#xD;
&#xD;
          -  Charcot foot disease&#xD;
&#xD;
          -  Radiographic evidence of open physes&#xD;
&#xD;
          -  Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index&#xD;
             ankle or hindfoot joint(s)&#xD;
&#xD;
          -  Requires osteotomy or fusion of the midfoot joints&#xD;
&#xD;
          -  BMI greater than 45 kg/m^2&#xD;
&#xD;
          -  Documented medical history of, or radiographic evidence of, a bone disease (e.g.&#xD;
             avascular necrosis) or other condition (e.g., osteolysis) that would preclude the&#xD;
             subject from receiving screw fixation in the opinion of the surgeon&#xD;
&#xD;
          -  Requires intramedullary nail fixation or an external fixator&#xD;
&#xD;
          -  Comorbidity that would limit the ability to administer any functional measurements&#xD;
             such as FAAM-ADL&#xD;
&#xD;
          -  Has at the time of surgery, a systemic infection or local infection at the site of&#xD;
             surgery&#xD;
&#xD;
          -  Medical condition, serious intercurrent illness, or extenuating circumstance that, in&#xD;
             the opinion of the Investigator, would preclude participation in the study or&#xD;
             potentially decrease survival or interfere with ambulation or rehabilitation (e.g.,&#xD;
             history of transient ischemic attack, stroke or liver disease)&#xD;
&#xD;
          -  HgbA1c level greater than or equal to 8%&#xD;
&#xD;
          -  Known hypersensitivity to any of the components of the product [e.g. B2A peptide,&#xD;
             Hydroxyapatite (HA): beta-tricalcium phosphate (βTCP), ceramic granule]&#xD;
&#xD;
          -  Currently receiving treatment with a drug known to interfere with bone metabolism&#xD;
             [e.g., systemic corticosteroid therapy (topical corticosteroid therapy is&#xD;
             permissible), methotrexate]&#xD;
&#xD;
          -  Has previously received treatment with a drug known to interfere with bone metabolism&#xD;
             [e.g., systemic corticosteroid therapy (topical corticosteroid therapy is&#xD;
             permissible), methotrexate] and in the opinion of the investigator could continue to&#xD;
             negatively interfere with bone metabolism or bone healing&#xD;
&#xD;
          -  History of any severe allergy or anaphylaxis, or a history of hypersensitivity to&#xD;
             protein pharmaceuticals [e.g., monoclonal antibodies or gamma globulins, recombinant&#xD;
             Bone Morphogenetic Proteins (BMPs)]&#xD;
&#xD;
          -  Medical condition requiring radiation, chemotherapy or immunosuppression&#xD;
&#xD;
          -  Have a prior or active history of malignancy (except for basal cell carcinoma of the&#xD;
             skin)&#xD;
&#xD;
          -  Has a history of autoimmune disease known to affect bone metabolism. Examples include&#xD;
             spondyloarthropathies (e.g., ankylosing spondylitis, Crohn's disease, and ulcerative&#xD;
             colitis), Juvenile Arthritis, Grave's disease and Hashimoto's thyroiditis; Rheumatoid&#xD;
             Arthritis is allowed&#xD;
&#xD;
          -  Have pathological or genetic liver disease or who have clinically significant,&#xD;
             elevated baseline liver function enzymes&#xD;
&#xD;
          -  Has obvious and/or documented alcohol or illicit drug addictions&#xD;
&#xD;
          -  Is a prisoner in a correctional institution/facility&#xD;
&#xD;
          -  Actively involved in litigation or workman's compensation&#xD;
&#xD;
          -  Has participated in clinical studies evaluating investigational devices,&#xD;
             pharmaceuticals or biologics within 6 months of randomization&#xD;
&#xD;
          -  Requires chronic therapeutic use of NSAID during the first 6 post-operative weeks&#xD;
             (except aspirin up to 325 mg bid for cardiovascular protection and/or DVT prophylaxis)&#xD;
&#xD;
          -  Has previously been treated with, or exposed to, therapeutic levels of synthetic or&#xD;
             recombinant BMPs&#xD;
&#xD;
          -  Requires chronic subcutaneous or intravenous heparin therapies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Compliance</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physician Research Group</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Orthopaedics</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado School of Medicine</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Orthopaedic and Sports Medicine Center</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Orthopaedic and Spine Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Orthopedics at Rush</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore, Inc / Rubin Institute for Advanced Orthopedics</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Associates of Michigan, Research and Education Institute</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Orthopedic Center</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TRIA Orthopaedic Center</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Orthopaedic Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester School of Medicine</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute, Inc.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reconstructive Orthopaedic Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopedics Center</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campbell Clinic Orthopaedics</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-0165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta System</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Alberta Orthopedics</name>
      <address>
        <city>Red Deer</city>
        <state>Alberta</state>
        <zip>T4N 6S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Laval</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>January 8, 2021</results_first_submitted>
  <results_first_submitted_qc>February 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2021</results_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03028415/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03028415/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 19 sites (14 sites in the United States and 5 sites in Canada) between July 2017 to July 2020.</recruitment_details>
      <pre_assignment_details>A total of 80 subjects were screened in the trial, of which, 56 subjects were randomized. All the 56 randomized subjects were exposed to graft material: 39 subjects were exposed to AMPLEX and 17 subjects were exposed to autogenous bone graft (ABG).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AMPLEX</title>
          <description>AMPLEX: A bone graft substitute</description>
        </group>
        <group group_id="P2">
          <title>Autogenous Bone Graft (ABG)</title>
          <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intention-to-treat (mITT) Population</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued due to COVID-19</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AMPLEX</title>
          <description>AMPLEX: A bone graft substitute</description>
        </group>
        <group group_id="B2">
          <title>Autogenous Bone Graft (ABG)</title>
          <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.4" spread="12.0"/>
                    <measurement group_id="B2" value="50.5" spread="14.4"/>
                    <measurement group_id="B3" value="53.9" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint</title>
        <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
        <time_frame>At week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint</title>
          <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5"/>
                    <measurement group_id="O2" value="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success</title>
        <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
        <time_frame>At week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success</title>
          <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.&#xD;
The last observation carried forward was used for subjects with missing response status at 52 weeks.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving CT Radiographic Fusion Success</title>
        <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
        <time_frame>At week 12</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving CT Radiographic Fusion Success</title>
          <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4"/>
                    <measurement group_id="O2" value="58.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving CT Radiographic Fusion Success</title>
        <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
        <time_frame>At week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving CT Radiographic Fusion Success</title>
          <description>Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0"/>
                    <measurement group_id="O2" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
        <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>Baseline, and at week 12</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
          <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.4"/>
                    <measurement group_id="O2" value="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
        <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>Baseline, and at week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
          <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9"/>
                    <measurement group_id="O2" value="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
        <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>Baseline, and at week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (&gt;20 mm Reduction From Baseline on 100 mm VAS)</title>
          <description>Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6"/>
                    <measurement group_id="O2" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
        <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>At week 2</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
          <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
        <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>At week 6</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
          <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
        <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>At week 12</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
          <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
        <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>At week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
          <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
        <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
        <time_frame>At week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Absence of Graft Harvest Site Pain (&lt;20 mm on 100 mm VAS)</title>
          <description>Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being &quot;no pain&quot; and 100 mm being &quot;the worst pain imaginable&quot;.&#xD;
Absence of significant graft harvest site pain was defined as &lt;20 mm on 100 mm VAS, and is presented for this outcome measure.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FAAM-ADL</title>
        <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
        <time_frame>Baseline, and at week 12</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FAAM-ADL</title>
          <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.16" spread="27.67"/>
                    <measurement group_id="O2" value="7.17" spread="20.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FAAM-ADL</title>
        <description>Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
        <time_frame>Baseline, and at week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FAAM-ADL</title>
          <description>Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.36" spread="23.82"/>
                    <measurement group_id="O2" value="13.28" spread="17.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FAAM-ADL</title>
        <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
        <time_frame>Baseline, and at week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FAAM-ADL</title>
          <description>Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.99" spread="21.51"/>
                    <measurement group_id="O2" value="11.37" spread="21.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Performance Composite (SPC) Endpoint</title>
        <description>Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).</description>
        <time_frame>At week 12</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Performance Composite (SPC) Endpoint</title>
          <description>Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5"/>
                    <measurement group_id="O2" value="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Performance Composite (SPC) Endpoint</title>
        <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).</description>
        <time_frame>At week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Performance Composite (SPC) Endpoint</title>
          <description>Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (&lt;20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-12 (SF-12)</title>
        <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
        <time_frame>Baseline, and at week 24</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-12 (SF-12)</title>
          <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-12 Physical component summary (Week 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="11.2"/>
                    <measurement group_id="O2" value="5.3" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-12 Mental component summary (Week 24)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="12.5"/>
                    <measurement group_id="O2" value="-3.6" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Short Form-12 (SF-12)</title>
        <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
        <time_frame>Baseline, and at week 52</time_frame>
        <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>AMPLEX</title>
            <description>AMPLEX: A bone graft substitute</description>
          </group>
          <group group_id="O2">
            <title>Autogenous Bone Graft (ABG)</title>
            <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Short Form-12 (SF-12)</title>
          <description>The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.</description>
          <population>The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-12 Physical component summary (Week 52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="10.7"/>
                    <measurement group_id="O2" value="3.8" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-12 Mental component summary (Week 52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="11.6"/>
                    <measurement group_id="O2" value="-0.8" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the signing of the informed consent up to 78 weeks</time_frame>
      <desc>A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.</desc>
      <group_list>
        <group group_id="E1">
          <title>AMPLEX</title>
          <description>AMPLEX: A bone graft substitute</description>
        </group>
        <group group_id="E2">
          <title>Autogenous Bone Graft (ABG)</title>
          <description>Autogenous Bone Graft (ABG): Control material administered by surgical implant</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Implant site irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Implant site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Incision site hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Incision site swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Eschar</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Compliance</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <phone>-+1 833-548-1402</phone>
      <email>DK0-Disclosure@ferring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028415
org study id: 000226
secondary id: G150153
nct id: NCT03028415
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in
      a population indicated for single, double, or triple hindfoot arthrodesis or ankle
      arthrodesis surgery with supplemental graft material.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint
time frame: At week 52
description: Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52).
The last observation carried forward was used for subjects with missing response status at 52 weeks.
measure: Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success
time frame: At week 52
description: Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
The last observation carried forward was used for subjects with missing response status at 52 weeks.
measure: Proportion of Subjects Achieving CT Radiographic Fusion Success
time frame: At week 12
description: Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
measure: Proportion of Subjects Achieving CT Radiographic Fusion Success
time frame: At week 24
description: Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
measure: Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
time frame: Baseline, and at week 12
description: Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
time frame: Baseline, and at week 24
description: Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)
time frame: Baseline, and at week 52
description: Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
time frame: At week 2
description: Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
time frame: At week 6
description: Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
time frame: At week 12
description: Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
time frame: At week 24
description: Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
measure: Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS)
time frame: At week 52
description: Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable".
Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure.
measure: Change From Baseline in FAAM-ADL
time frame: Baseline, and at week 12
description: Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
measure: Change From Baseline in FAAM-ADL
time frame: Baseline, and at week 24
description: Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
measure: Change From Baseline in FAAM-ADL
time frame: Baseline, and at week 52
description: Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction.
measure: Subject Performance Composite (SPC) Endpoint
time frame: At week 12
description: Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12).
measure: Subject Performance Composite (SPC) Endpoint
time frame: At week 24
description: Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24).
measure: Change From Baseline in Short Form-12 (SF-12)
time frame: Baseline, and at week 24
description: The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.
measure: Change From Baseline in Short Form-12 (SF-12)
time frame: Baseline, and at week 52
description: The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better.
arm group label: AMPLEX
arm group type: Experimental
arm group label: Autogenous Bone Graft (ABG)
arm group type: Active Comparator
intervention type: Device
intervention name: AMPLEX
description: A bone graft substitute
arm group label: AMPLEX
intervention type: Procedure
intervention name: Autogenous Bone Graft (ABG)
description: Control material administered by surgical implant
arm group label: Autogenous Bone Graft (ABG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Global Clinical Compliance
role: Study Director
affiliation: Ferring Pharmaceuticals
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country: Canada
country: United States
responsible party type: Sponsor
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