<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/NCT02250248</url>
  </required_header>
  <id_info>
    <org_study_id>NUVA.AX1401</org_study_id>
    <nct_id>NCT02250248</nct_id>
  </id_info>
  <brief_title>AttraX® Putty vs. Autograft in XLIF®</brief_title>
  <official_title>AttraX® Putty vs. Autograft in eXtreme Lateral Interbody Fusion (XLIF®): A Prospective Randomized Single-Center Evaluation of Radiographic and Clinical Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NuVasive</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NuVasive</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the clinical success of AttraX Putty as a bone&#xD;
      graft substitute for autograft in XLIF procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, prospective, randomized study. Subjects will be recruited from&#xD;
      patients already under the Investigator's care who are indicated for XLIF with iliac crest&#xD;
      bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a&#xD;
      given investigational site who meet eligibility requirements will be asked to consent to&#xD;
      participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be&#xD;
      randomly assigned. All subjects will be followed for 24 months following surgery to quantify&#xD;
      the clinical and radiographic improvements of each biologic compared to baseline and in&#xD;
      comparison with each other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">May 21, 2021</completion_date>
  <primary_completion_date type="Actual">May 21, 2021</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number and percentage of subjects with radiographically apparent fusion 24 months.</measure>
    <time_frame>24-months</time_frame>
    <description>The number and percentage of subjects with radiographically apparent fusion 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of complications attributable to the use of AttraX and ICBG autograft.</measure>
    <time_frame>Post-op to 24-months</time_frame>
    <description>The rate of complications attributable to the use of AttraX and ICBG autograft.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.</measure>
    <time_frame>Pre-op through 24-months</time_frame>
    <description>The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.</measure>
    <time_frame>Surgery through 24-months</time_frame>
    <description>The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Degenerative Conditions of the Lumbar Spine</condition>
  <arm_group>
    <arm_group_label>AttraX Putty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will be treated with AttraX Putty intraoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iliac Crest Bone Graft (ICBG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be treated with ICBG harvested during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AttraX Putty</intervention_name>
    <arm_group_label>AttraX Putty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Iliac Crest Bone Graft (ICBG)</intervention_name>
    <arm_group_label>Iliac Crest Bone Graft (ICBG)</arm_group_label>
    <other_name>autograft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Persistent back and/or leg pain unresponsive to conservative treatment for at least 6&#xD;
             months, unless surgical treatment is clinically indicated sooner&#xD;
&#xD;
          2. Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous&#xD;
             pedicle screws&#xD;
&#xD;
          3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging&#xD;
             studies&#xD;
&#xD;
          4. 18-80 years of age at the date of written informed consent&#xD;
&#xD;
          5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment&#xD;
&#xD;
          6. Expected to survive at least 2 years beyond surgery&#xD;
&#xD;
          7. Willing and able to return for post-treatment exams according to the follow-up called&#xD;
             for in the protocol&#xD;
&#xD;
          8. Signed and dated informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mental or physical condition that would limit the ability to comply with study&#xD;
             requirements&#xD;
&#xD;
          2. Spine abnormality requiring treatment at more than one level&#xD;
&#xD;
          3. Previous failed fusion at any spinal level&#xD;
&#xD;
          4. Prior fusion procedure at operative level (i.e., no revision of operative level)&#xD;
&#xD;
          5. Prior adjacent level fusion (note: prior decompression is not an exclusion)&#xD;
&#xD;
          6. Systemic or local infection; active or latent&#xD;
&#xD;
          7. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of&#xD;
             osteoporosis, metabolic bone disease)&#xD;
&#xD;
          8. Treatment with pharmaceuticals interfering with calcium metabolism&#xD;
&#xD;
          9. Undergoing chemotherapy or radiation treatment&#xD;
&#xD;
         10. Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months&#xD;
             of surgery, other than episodic use or inhaled corticosteroids)&#xD;
&#xD;
         11. Involvement in active litigation relating to the spine (worker's compensation claim is&#xD;
             allowed if it is not contested)&#xD;
&#xD;
         12. Significant general illness (e.g., HIV, active metastatic cancer of any type,&#xD;
             uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)&#xD;
&#xD;
         13. Immunocompromised or is being treated with immunosuppressive agents&#xD;
&#xD;
         14. Pregnant, or plans to become pregnant during the study&#xD;
&#xD;
         15. Subject is a prisoner&#xD;
&#xD;
         16. Participating in another clinical study that would confound study data&#xD;
&#xD;
         17. At risk to be non-compliant (e.g. (recently treated for) substance abuse, detainee,&#xD;
             likely to immigrate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristiano M Menezes, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lifecenter to Mater Dei Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mater Dei Hospital</name>
      <address>
        <city>Barro Preto</city>
        <state>Minas Gerais</state>
        <zip>30140-093</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Degenerative disc disease</keyword>
  <keyword>Lumbar spine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02250248
org study id: NUVA.AX1401
nct id: NCT02250248
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone
      graft substitute for autograft in XLIF procedures.
This is a single-center, prospective, randomized study. Subjects will be recruited from
      patients already under the Investigator's care who are indicated for XLIF with iliac crest
      bone graft (ICBG) autograft or AttraX Putty. To minimize bias, all consecutive patients at a
      given investigational site who meet eligibility requirements will be asked to consent to
      participate in the study whereby the biologic (ICBG autograft or AttraX Putty) will be
      randomly assigned. All subjects will be followed for 24 months following surgery to quantify
      the clinical and radiographic improvements of each biologic compared to baseline and in
      comparison with each other.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The number and percentage of subjects with radiographically apparent fusion 24 months.
time frame: 24-months
description: The number and percentage of subjects with radiographically apparent fusion 24 months.
measure: The rate of complications attributable to the use of AttraX and ICBG autograft.
time frame: Post-op to 24-months
description: The rate of complications attributable to the use of AttraX and ICBG autograft.
measure: The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
time frame: Pre-op through 24-months
description: The change in self-reported clinical outcomes scores from baseline through 24 month follow-up, including VAS (back, leg, and iliac crest pain), ODI, EQ5D, and SF-36.
measure: The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.
time frame: Surgery through 24-months
description: The morbidity associated graft harvest as measured by operative time, blood loss, length of hospital stay, postoperative pain, and infection rate.
arm group label: AttraX Putty
arm group type: Active Comparator
description: Patient will be treated with AttraX Putty intraoperatively.
arm group label: Iliac Crest Bone Graft (ICBG)
arm group type: Active Comparator
description: Patients will be treated with ICBG harvested during surgery.
intervention type: Biological
intervention name: AttraX Putty
arm group label: AttraX Putty
intervention type: Other
intervention name: Iliac Crest Bone Graft (ICBG)
arm group label: Iliac Crest Bone Graft (ICBG)
other name: autograft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Cristiano M Menezes, M.D.
role: Principal Investigator
affiliation: Lifecenter to Mater Dei Hospital
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: No