xml: <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/NCT05997381</url>
    </required_header>
    <id_info>
      <org_study_id>CSP-BB0003</org_study_id>
      <nct_id>NCT05997381</nct_id>
    </id_info>
    <brief_title>BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears</brief_title>
    <official_title>A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CONMED Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CONMED Corporation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair&#xD;
        augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects&#xD;
        requiring surgical intervention for a full-thickness rotator cuff tear.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical&#xD;
        study investigating the treatment of full thickness tears of the rotator cuff. Tears must&#xD;
        involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and &lt; 5 cm.&#xD;
        Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either&#xD;
        arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator&#xD;
        cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and&#xD;
        at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome&#xD;
        measures and MRI to assess repair integrity and re-tear rate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>6 Month Retear Rate</measure>
      <time_frame>6 months post-op</time_frame>
      <description>The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>12 Month Retear Rate</measure>
      <time_frame>12 months post-op</time_frame>
      <description>The between-group difference in radiological incidence (MRI) of Sugaya Type IV or V full-thickness discontinuity at postoperative Month 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Single Assessment Numeric Evaluation (SANE)</measure>
      <time_frame>Baseline, 6 weeks, 3-, 6-, and 12-months post-op</time_frame>
      <description>Adjusted mean between-group difference in SANE score from baseline to 6 weeks, 3-, 6-, and 12-months post-op</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario Rotator Cuff Index (WORC)</measure>
      <time_frame>Baseline, 6 weeks, 3-, 6-, and 12-months post-op</time_frame>
      <description>Adjusted mean between-group difference in WORC score from baseline to 6 weeks, 3-, 6-, and 12-months post-op</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)</measure>
      <time_frame>Baseline, 6 weeks, 3-, 6-, and 12-months post-op</time_frame>
      <description>Adjusted mean between-group difference in health-related, quality of life from baseline to 6 weeks, 3-, 6-, and 12-months post-op</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">268</enrollment>
    <condition>Rotator Cuff Tears</condition>
    <arm_group>
      <arm_group_label>BioBrace Augment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Repair Only Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>An arthroscopic rotator cuff repair is performed using standard surgical procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.</intervention_name>
      <description>An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.</description>
      <arm_group_label>BioBrace Augment Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Arthroscopic rotator cuff repair</intervention_name>
      <description>An arthroscopic rotator cuff repair is performed using standard surgical procedure.</description>
      <arm_group_label>Repair Only Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female 40 to 70 years old&#xD;
  &#xD;
            2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder&#xD;
               indicating a full thickness rotator cuff tear (RCT):&#xD;
  &#xD;
                 1. Tear of the supraspinatus and/or infraspinatus tendons&#xD;
  &#xD;
                 2. Tear size ≥ 2 cm and &lt; 5 cm&#xD;
  &#xD;
            3. Chronic shoulder pain ≥ 3 months&#xD;
  &#xD;
            4. Failed non-operative treatment of the index shoulder to include one or all of the&#xD;
               following:&#xD;
  &#xD;
                 1. Oral analgesics&#xD;
  &#xD;
                 2. Nonsteroidal anti-inflammatory medications (NSAIDs)&#xD;
  &#xD;
                 3. Corticosteroid injections&#xD;
  &#xD;
                 4. Activity modifications&#xD;
  &#xD;
                 5. Physical therapy or home-guided exercises&#xD;
  &#xD;
            5. Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)&#xD;
  &#xD;
            6. Willing to be available to attend each protocol-required follow-up examination&#xD;
  &#xD;
            7. Able to speak, read and understand English&#xD;
  &#xD;
          Intraoperative Inclusion Criteria:&#xD;
  &#xD;
            1. Full thickness tear of the supraspinatus and/or infraspinatus tendons&#xD;
  &#xD;
            2. Tear size ≥ 2 cm and &lt; 5 cm&#xD;
  &#xD;
            3. Able to reapproximate the tendons to cover &gt; 50% of the footprint on the greater&#xD;
               tuberosity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous surgery of the index shoulder one year prior to the study surgery excluding&#xD;
               diagnostic arthroscopy&#xD;
  &#xD;
            2. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier&#xD;
               Score)&#xD;
  &#xD;
            3. Major medical condition that could affect quality of life and influence the results of&#xD;
               the study (e.g., HIV or other immunosuppressive conditions, active malignancy in the&#xD;
               past 5 years, acute MI, CVA, etc.)&#xD;
  &#xD;
            4. Oral steroid use or steroid injection within 6 weeks prior to surgery&#xD;
  &#xD;
            5. Active smoker&#xD;
  &#xD;
            6. History of insulin-dependent diabetes&#xD;
  &#xD;
            7. Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12&#xD;
               months of enrollment&#xD;
  &#xD;
            8. Hypersensitivity to any investigational device materials including collagen of animal&#xD;
               origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)&#xD;
  &#xD;
            9. Presence of an implanted metallic device or other implants that would contraindicate&#xD;
               acquisition or inhibit radiologist review of an MRI of the index shoulder&#xD;
  &#xD;
           10. History of claustrophobia that would prevent an MRI of the index shoulder&#xD;
  &#xD;
           11. Females of child-bearing potential who are either pregnant or breastfeeding or plan to&#xD;
               become pregnant during the course of the study&#xD;
  &#xD;
           12. Currently participating, or plans to enroll in another clinical trial during this&#xD;
               study that would affect the outcomes of this study as determined by the Investigator&#xD;
  &#xD;
           13. History of non-compliance with medical treatment or clinical trial participation&#xD;
  &#xD;
           14. The subject is physically or mentally compromised (e.g., currently being treated for a&#xD;
               psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that&#xD;
               the Investigator judges the subject to be unable or unlikely to remain compliant with&#xD;
               protocol required follow-up&#xD;
  &#xD;
           15. Any comorbidity or condition that renders the patient a poor surgical candidate as&#xD;
               determined by the Investigator&#xD;
  &#xD;
           16. The subject is receiving prescription narcotic pain medication&#xD;
  &#xD;
           17. The subject currently has an acute infection in the area surrounding the surgical site&#xD;
  &#xD;
           18. Contralateral shoulder condition where rotator cuff repair is scheduled or to be&#xD;
               scheduled over the course of this study&#xD;
  &#xD;
           19. The subject's condition represents a worker's compensation case&#xD;
  &#xD;
           20. COVID-19 positive at hospital admission&#xD;
  &#xD;
          Intraoperative Exclusion Criteria:&#xD;
  &#xD;
          1. Subject requires subscapularis repair other than a repair with a single anchor&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gowri Viswanathan, MS</last_name>
      <phone>914-334-2498</phone>
      <email>GowriViswanathan@conmed.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeffery Grebner, MS</last_name>
      <phone>651-367-4956</phone>
      <email>JefferyGrebner@conmed.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rotator cuff tear</keyword>
    <keyword>Full thickness tear</keyword>
    <keyword>BioBrace</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997381
  org study id: CSP-BB0003
  nct id: NCT05997381
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair
        augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects
        requiring surgical intervention for a full-thickness rotator cuff tear.
  This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical
        study investigating the treatment of full thickness tears of the rotator cuff. Tears must
        involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and < 5 cm.
        Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either
        arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator
        cuff repair alone. Clinical evaluations will be conducted at baseline (pre-operatively) and
        at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome
        measures and MRI to assess repair integrity and re-tear rate.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: 6 Month Retear Rate
  time frame: 6 months post-op
  description: The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.
  measure: 12 Month Retear Rate
  time frame: 12 months post-op
  description: The between-group difference in radiological incidence (MRI) of Sugaya Type IV or V full-thickness discontinuity at postoperative Month 12.
  measure: Single Assessment Numeric Evaluation (SANE)
  time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
  description: Adjusted mean between-group difference in SANE score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
  measure: Western Ontario Rotator Cuff Index (WORC)
  time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
  description: Adjusted mean between-group difference in WORC score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
  measure: EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)
  time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
  description: Adjusted mean between-group difference in health-related, quality of life from baseline to 6 weeks, 3-, 6-, and 12-months post-op
  arm group label: BioBrace Augment Group
  arm group type: Experimental
  description: An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.
  arm group label: Repair Only Group
  arm group type: Sham Comparator
  description: An arthroscopic rotator cuff repair is performed using standard surgical procedure.
  intervention type: Device
  intervention name: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.
  description: An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant. The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair. The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.
  arm group label: BioBrace Augment Group
  intervention type: Procedure
  intervention name: Arthroscopic rotator cuff repair
  description: An arthroscopic rotator cuff repair is performed using standard surgical procedure.
  arm group label: Repair Only Group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gowri Viswanathan, MS
  phone: 914-334-2498
  email: GowriViswanathan@conmed.com
  last name: Jeffery Grebner, MS
  phone: 651-367-4956
  email: JefferyGrebner@conmed.com
  responsible party type: Sponsor
  mesh term: Rotator Cuff Injuries