<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/NCT02225444</url>
  </required_header>
  <id_info>
    <org_study_id>TP1020</org_study_id>
    <nct_id>NCT02225444</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®</brief_title>
  <official_title>A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP® to Evaluate Long-Term Safety and Efficacy in Patients Requiring 1-2 Level Instrumented PLF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioventus LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bioventus LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain&#xD;
      multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain&#xD;
      a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to&#xD;
      garner FDA regulatory approval. This is a prospective, non-randomized, non-controlled,&#xD;
      multi-center study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in&#xD;
      patients with degenerative disc disease, degenerative spondylolisthesis (up to grade 1),&#xD;
      and/or mild degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to&#xD;
      undergo instrumented, posterolateral spinal fusion surgery as part of their medical treatment&#xD;
      and comply with the study eligibility criteria will be given the opportunity to consent and&#xD;
      be entered into the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this clinical study are: to evaluate the long term efficacy of OsteoAMP in&#xD;
      patients requiring 1 to 2 adjacent level, instrumented posterolateral spinal fusion procedure&#xD;
      of the lumbar or lumbosacral spine, and to evaluate OsteoAMP in spinal fusion procedures&#xD;
      based on fusion results, adverse event rates, and pain and health scores.&#xD;
&#xD;
      Patients that are scheduled to undergo instrumented, posterolateral spinal fusion (PLF)&#xD;
      surgery as part of their medical treatment and comply with the study eligibility criteria&#xD;
      will be recruited and entered into the study. Subjects recruited into the study will receive&#xD;
      OsteoAMP as part of an instrumented PLF surgical procedure. The surgery may also include&#xD;
      nerve root decompressions through laminectomies and foraminotomies. As is consistent with the&#xD;
      current standard of care.&#xD;
&#xD;
      The study involves consecutive patients suffering from lower back and leg pain due to&#xD;
      degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild&#xD;
      degenerative scoliosis that are candidates for an instrumented PLF with pedicle screws in 1&#xD;
      or 2 motion segments of the lumbar or lumbosacral spine. Patients will require a total bone&#xD;
      graft volume of at least 10cc per side per level in the PLF procedure, including OsteoAMP&#xD;
      granules hydrated with bone marrow aspirate (BMA) and local autogenous bone.&#xD;
&#xD;
      Subjects will be followed for 24 months post-surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2015</start_date>
  <completion_date type="Actual">October 11, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Posterolateral fusion evaluation as determined by physician's assessment</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Radiographic evidence of fusion assessed by flexion-extension and CT radiograph or computed tomography (CT) scans.&#xD;
Flexion extension radiographs timeframe: Pre-op, 6 month, 12 month, 24 months&#xD;
CT timeframe: 12 month, 24 month. NOTE: If subject determined to be fused at 12 months, 24 month x-rays and CT not required</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement form baseline low back pain</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Improvement form baseline in low back pain and function as measured by Oswestry Disability Index (ODI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvements in pain</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Visual Analogue Scale (VAS) improvement from baseline to 24 month follow up assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in function</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Short Form 36 (SF-36) score improvement compared to baseline at 24 months assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posterolateral fusion as determined by independently scored and adjudicated assessment</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Radiographic evidence of fusion assessed by flexion-extension and CT at 12 months and 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in Other Health-Related Quality of Life measures</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Health-Related Quality of Life measures; work status, use of medication and perception of treatment effectiveness at Weeks 6 Post- Surgery, 3 months, 6 months, 12 months and 24 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maintenance or improvement from baseline in neurological status with no new permanent deficits</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Neurological exam</description>
  </other_outcome>
  <other_outcome>
    <measure>Absence of serious product-related adverse events</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Serious product-related adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Freedom from subsequent product-related surgical interventions</measure>
    <time_frame>24 month follow up</time_frame>
    <description>Interventions include revision, removal, re-operation, and supplemental fixation at the affected level(s)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Spondylolisthesis</condition>
  <condition>Scoliosis</condition>
  <condition>Intervertebral Disc Disease</condition>
  <arm_group>
    <arm_group_label>OsteoAMP treatment group</arm_group_label>
    <description>The OsteoAMP treatment group contains patients randomized to receive their own bone (retrieved from the surgical site) augmented with the OsteoAMP growth factor to assist with posterolateral arthrodesis at 1 or 2 adjacent levels between L1-S1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OsteoAMP</intervention_name>
    <description>OsteoAMP in posterolateral fusion procedure of the lumbosacral spine</description>
    <arm_group_label>OsteoAMP treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female patients between 21 and 75 years old with degenerative disc disease,&#xD;
        degenerative spondylolisthesis (up to grade 1), and/or mild degenerative scoliosis (up to&#xD;
        25° curvature) that have failed conservative treatment and are now indicated for&#xD;
        instrumented posterolateral spinal fusion at 1 or 2 contiguous levels between L1-S1.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Summary of Inclusion Criteria:&#xD;
&#xD;
          1. Aged 21 to 85 years and skeletally mature at time of surgery&#xD;
&#xD;
          2. Diagnosis of degenerative disc disease (DDD), degenerative spondylolisthesis (up to&#xD;
             grade 1), and/or mild degenerative scoliosis (up to 25°) curvature&#xD;
&#xD;
          3. One or more of the following are met: -instability (defined a angulation greater than&#xD;
             or equal to 5 degrees and/or translation greater than or equal 4mm based on&#xD;
             flexion/extension radiographs, -osteophyte formation, - decreased disc height, -&#xD;
             thickening of ligamentous tissue, disc degeneration or herniation,- facet joint&#xD;
             degeneration&#xD;
&#xD;
          4. Requires fusion (i.e., Symptomatic) at up to two contiguous levels from L1 to S1.&#xD;
&#xD;
          5. Preoperative ODI score of more than 30&#xD;
&#xD;
          6. Non-responsive to non-operative treatment for at least 6 months.&#xD;
&#xD;
          7. Lower back pain with or without claudication.&#xD;
&#xD;
          8. If of child-bearing potential, non-pregnant, non-nursing, and agrees to use&#xD;
             contraception for up to 2 years following surgery&#xD;
&#xD;
          9. Willing and able to comply with study plan and able to understand and sign informed&#xD;
             consent&#xD;
&#xD;
        Summary of Exclusion Criteria&#xD;
&#xD;
          1. Primary diagnosis of a spinal disorder other than DDD, degenerative spondylolisthesis&#xD;
             up to Grade 1 or mild degenerative scoliosis of up to 25 degrees curvature&#xD;
&#xD;
          2. Requires fusion of more than 2 vertebral levels or of 2 non-adjacent vertebral levels&#xD;
&#xD;
          3. Conditions requiring medications that interfere with fusion or bone metabolism&#xD;
&#xD;
          4. More than one immobile vertebral level between L1 and S1 from any cause&#xD;
&#xD;
          5. Overt or active local or systemic infection, including latent infection around the&#xD;
             surgical implantation site&#xD;
&#xD;
          6. Clinically severe obesity as defined by the National Institutes of Health&#xD;
&#xD;
          7. Uncontrolled diabetes mellitus as confirmed by HbA1c greater than 8%&#xD;
&#xD;
          8. History of osteoporosis or other metabolic bone disorders, including Paget's disease&#xD;
             and osteomalacia&#xD;
&#xD;
          9. History of hypersensitivity to any of the agents used to process OsteoAMP&#xD;
&#xD;
         10. History of autoimmune disease&#xD;
&#xD;
         11. Received other bone graft substitutes&#xD;
&#xD;
         12. Received medication that may interfere with fusion or bone metabolism within 2 weeks&#xD;
             of planned surgery&#xD;
&#xD;
         13. Received or plans to receive investigational therapy&#xD;
&#xD;
         14. Presence of active malignancy unless he/she has been treated with curative intent and&#xD;
             there have been no clinical signs or symptoms of malignancy for at least 3 years&#xD;
&#xD;
         15. Presence of systemic disease or condition, which affects his/her ability to&#xD;
             participate in the study requirements or the ability to evaluate the efficacy of the&#xD;
             product&#xD;
&#xD;
         16. Prisoner, transient, or has been treated for chemical/alcohol dependency in an&#xD;
             inpatient substance abuse program within 6 months prior to study enrollment or has&#xD;
             significant psychosocial disturbance that would affect participation in the study, in&#xD;
             the opinion of the investigator&#xD;
&#xD;
         17. Any condition for which the surgical procedure, in the opinion of the Investigator,&#xD;
             poses an undue risk&#xD;
&#xD;
         18. Pursuing litigation related to cervical and/or lumbar/lumbosacral spine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Daffner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Howard An, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Medical School</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Institute of Western KY</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rothman Institute</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoCarolina Research Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>degenerative lumbosacral spine disease</keyword>
  <keyword>posterolateral fusion evaluation</keyword>
  <keyword>OsteoAMP</keyword>
  <keyword>autograft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02225444
org study id: TP1020
nct id: NCT02225444
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain
      multiple endogenous growth factors for use in spinal fusion. The study is designed to obtain
      a higher level of clinical evidence for OsteoAMP in spinal fusion procedures and not to
      garner FDA regulatory approval. This is a prospective, non-randomized, non-controlled,
      multi-center study of OsteoAMP in instrumented, posterolateral lumbar fusion (PLF) in
      patients with degenerative disc disease, degenerative spondylolisthesis (up to grade 1),
      and/or mild degenerative scoliosis, up to 25 degree curvature. Patients that are scheduled to
      undergo instrumented, posterolateral spinal fusion surgery as part of their medical treatment
      and comply with the study eligibility criteria will be given the opportunity to consent and
      be entered into the study.
The objective of this clinical study are: to evaluate the long term efficacy of OsteoAMP in
      patients requiring 1 to 2 adjacent level, instrumented posterolateral spinal fusion procedure
      of the lumbar or lumbosacral spine, and to evaluate OsteoAMP in spinal fusion procedures
      based on fusion results, adverse event rates, and pain and health scores.

      Patients that are scheduled to undergo instrumented, posterolateral spinal fusion (PLF)
      surgery as part of their medical treatment and comply with the study eligibility criteria
      will be recruited and entered into the study. Subjects recruited into the study will receive
      OsteoAMP as part of an instrumented PLF surgical procedure. The surgery may also include
      nerve root decompressions through laminectomies and foraminotomies. As is consistent with the
      current standard of care.

      The study involves consecutive patients suffering from lower back and leg pain due to
      degenerative disc disease (DDD), degenerative spondylolisthesis (up to grade 1), and/or mild
      degenerative scoliosis that are candidates for an instrumented PLF with pedicle screws in 1
      or 2 motion segments of the lumbar or lumbosacral spine. Patients will require a total bone
      graft volume of at least 10cc per side per level in the PLF procedure, including OsteoAMP
      granules hydrated with bone marrow aspirate (BMA) and local autogenous bone.

      Subjects will be followed for 24 months post-surgery.
observational model: Cohort
time perspective: Prospective
measure: Posterolateral fusion evaluation as determined by physician's assessment
time frame: 24 month follow up
description: Radiographic evidence of fusion assessed by flexion-extension and CT radiograph or computed tomography (CT) scans.
Flexion extension radiographs timeframe: Pre-op, 6 month, 12 month, 24 months
CT timeframe: 12 month, 24 month. NOTE: If subject determined to be fused at 12 months, 24 month x-rays and CT not required
measure: Improvement form baseline low back pain
time frame: 24 month follow up
description: Improvement form baseline in low back pain and function as measured by Oswestry Disability Index (ODI)
measure: Improvements in pain
time frame: 24 month follow up
description: Visual Analogue Scale (VAS) improvement from baseline to 24 month follow up assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month
measure: Improvements in function
time frame: 24 month follow up
description: Short Form 36 (SF-36) score improvement compared to baseline at 24 months assessed at timeframes: Pre-Op, 6 weeks, 3 month, 6 month, 12 month, 24 month
measure: Posterolateral fusion as determined by independently scored and adjudicated assessment
time frame: 24 month follow up
description: Radiographic evidence of fusion assessed by flexion-extension and CT at 12 months and 24 months
measure: Improvements in Other Health-Related Quality of Life measures
time frame: 24 month follow up
description: Health-Related Quality of Life measures; work status, use of medication and perception of treatment effectiveness at Weeks 6 Post- Surgery, 3 months, 6 months, 12 months and 24 months
measure: Maintenance or improvement from baseline in neurological status with no new permanent deficits
time frame: 24 month follow up
description: Neurological exam
measure: Absence of serious product-related adverse events
time frame: 24 month follow up
description: Serious product-related adverse events
measure: Freedom from subsequent product-related surgical interventions
time frame: 24 month follow up
description: Interventions include revision, removal, re-operation, and supplemental fixation at the affected level(s)
arm group label: OsteoAMP treatment group
description: The OsteoAMP treatment group contains patients randomized to receive their own bone (retrieved from the surgical site) augmented with the OsteoAMP growth factor to assist with posterolateral arthrodesis at 1 or 2 adjacent levels between L1-S1.
intervention type: Other
intervention name: OsteoAMP
description: OsteoAMP in posterolateral fusion procedure of the lumbosacral spine
arm group label: OsteoAMP treatment group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Scott Daffner, MD
role: Principal Investigator
affiliation: West Virginia University
last name: Howard An, MD
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Spondylolisthesis