<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/NCT04450342</url>
  </required_header>
  <id_info>
    <org_study_id>REGENETEN.2020.01</org_study_id>
    <nct_id>NCT04450342</nct_id>
  </id_info>
  <brief_title>REGENETEN™ Bioinductive Implant System in Full-thickness Tears</brief_title>
  <acronym>REGENETEN</acronym>
  <official_title>A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, Inc.</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair&#xD;
      (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair&#xD;
      or revision repair versus Arthroscopic rotator cuff repair alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, multi-center, randomized, controlled clinical study in the&#xD;
      treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML&#xD;
      according to Cofield classification). The subjects meeting the inclusion/exclusion criteria&#xD;
      specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone.&#xD;
      Subjects enrolled into the revision repair subject group will receive ARCR augmented with&#xD;
      REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2&#xD;
      weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome&#xD;
      measures, objective measures of movement and an MRI scan to assess the integrity of the&#xD;
      repair and assess the re-tear rate. Health economic data will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Sponsor decision not related to safety.&#xD;
  </why_stopped>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">October 27, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 27, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 months retear rate</measure>
    <time_frame>6 months post surgery</time_frame>
    <description>The cumulative 6 months retear rate after full-thickness ARCR augmented with REGENETEN versus ARCR alone. Failure is defined as Sugaya Type IV or V retear/recurrence (fullthickness discontinuity seen on both coronal and oblique sagittal MRI images).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retear rate</measure>
    <time_frame>3, 6, 12, and 24 months</time_frame>
    <description>Cumulative 3, 6, 12, and 24 months retear rate after fullthickness ARCR augmented with REGENETEN (confirmed on MRI) versus ARCR alone. Failure is defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Shoulder Score (OSS)</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario Rotator Cuff (WORC)/Chinese version WORC (C-WORC) Index)</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC/CWORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant-Murley Score</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective shoulder value (SSV)</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>Overall performance of full-thickness ARCR augmented with REGENETEN versus ARCR alone at Baseline and at 3, 6, 12 and 24 months assessed by the Subjective Shoulder Value (SSV). The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas.&#xD;
The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction Questionnaire Outcome</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The Patient Satisfaction Questionnaire is a simple subjective assessment of the success of surgery from the patient's perspective. Pre-Op: will be documented on a visual analogue score of 0-100. Rated by the subject with 0 is the least satisfied, 100 the most satisfied.Post-Op:This includes the VAS Patient Satisfaction Score as for pre-Op and additional five questions ask of the patient:1. How well did the surgery relieve the pain? 2. How well did the surgery increase your ability to perform regular activities? 3. How well did the surgery allow you to perform heavy work or sport activities (if allowed by Dr)? 4. How well did the surgery meet your expectations? Questions rated by the patient with excellent, very good,good, fair and poor. 5. Would you have the operation again if needed on another joint? Question rated by the patient with Definitely yes, Probably yes, Possibly not, Definitely not Rated by the subject with 0 is the least satisfied, 100 the most satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, Visual analog scale (VAS) Score</measure>
    <time_frame>Baseline, 2 weeks, 6 weeks, 3 and 6 months</time_frame>
    <description>Overall performance of full-thickness ARCR augmented with REGENETEN versus ARCR alone at Baseline and at 3, 6,12 and 24 months assessed by the VAS Pain Score. Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Sugaya Score postoperatively</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The Sugaya score will be used to determine postoperative cuff integrity through magnetic resonance imaging classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Goutallier Classification postoperatively</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total tendon thickness, tendon length will be assessed by MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone postoperatively</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>Tendon thickness, length will be assessed by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of retear: anteroposterior [AP]/mediolateral [ML]) postoperatively</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>Size of retear will be based on MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shape of retear postoperatively</measure>
    <time_frame>Baseline, 3, 6, 12 and 24 months</time_frame>
    <description>Shape of retear will be based on MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of Return to Work Questionnaire in ARCR augmented with REGENETEN versus ARCR alone</measure>
    <time_frame>Baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months</time_frame>
    <description>Generic questionnaire, covering work related questions,including demographics on laborer/sedentary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative duration of opioid use in ARCR augmented with REGENETEN versus ARCR alone</measure>
    <time_frame>2 weeks</time_frame>
    <description>Self-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?' Y/N .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total operative time ARCR augmented with REGENETEN versus ARCR alone</measure>
    <time_frame>Intra-operative time</time_frame>
    <description>Total operative time ARCR augmented with REGENETEN versus ARCR alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sling type and mobilization time in ARCR augmented with REGENETEN versus ARCR alone</measure>
    <time_frame>3 months</time_frame>
    <description>The type of sling will be collected and presented for each treatment arm summarizing if standard sling, shoulder immobilizer, abduction sling, ER sling, or other were advised and mobilization time will be calculated for both arms summarizing mobilization duration.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Rotator Cuff Injuries</condition>
  <arm_group>
    <arm_group_label>ARCR augmented with REGENETEN™ Bioinductive Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARCR alone</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARCR revision group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ARCR revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation</intervention_name>
    <description>The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.</description>
    <arm_group_label>ARCR augmented with REGENETEN™ Bioinductive Implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic rotator cuff repair</intervention_name>
    <description>The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.</description>
    <arm_group_label>ARCR alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arthroscopic rotator cuff repair for revision surgery</intervention_name>
    <description>The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.</description>
    <arm_group_label>ARCR revision group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject requires Arthroscopic rotator cuff repair (ARCR);&#xD;
&#xD;
          2. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair&#xD;
             subject group), large or massive tear (≥ 3 cm AP/ML) of the supraspinatus and/or&#xD;
             infraspinatus tendons amenable to repair. For screening purposes, a ≥ 2 cm AP/ML tear&#xD;
             as measured on MRI will be eligible to proceed to the operative visit but will have to&#xD;
             be confirmed as ≥ 3 cm on arthroscopy using a calibrated probe to proceed;&#xD;
&#xD;
          3. Subject is &gt; 40 years of age (no upper limit);&#xD;
&#xD;
          4. Subject provides written informed consent for study participation using an Independent&#xD;
             Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;&#xD;
&#xD;
          5. Subject is willing and able to participate in required follow-up visits and is able to&#xD;
             complete study activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to&#xD;
             psychiatric or medical contraindications;&#xD;
&#xD;
          2. Subjects with Samilson-Prieto osteoarthritis &gt; 2;&#xD;
&#xD;
          3. Subjects with current or prior infection of the ipsilateral shoulder;&#xD;
&#xD;
          4. Subjects with known hypersensitivity to bovine-derived materials;&#xD;
&#xD;
          5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or&#xD;
             chronic joint disease;&#xD;
&#xD;
          6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision&#xD;
             repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE],&#xD;
             subacromial decompression);&#xD;
&#xD;
          7. Subjects with an irreparable or partially reparable rotator cuff tear;&#xD;
&#xD;
          8. Subjects with a subscapularis tear requiring repair;&#xD;
&#xD;
          9. Subjects requiring a concomitant labral fixation procedure;&#xD;
&#xD;
         10. Subjects requiring a concomitant os acromiale fixation procedure;&#xD;
&#xD;
         11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);&#xD;
&#xD;
         12. Subjects with a subacromial or intra-articular injection within 3 months prior to&#xD;
             surgery;&#xD;
&#xD;
         13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., &gt;&#xD;
             Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy &gt; Grade 3, proximal&#xD;
             humeral fracture or scapular fracture, avascular necrosis of the humeral head or&#xD;
             glenoid, history of immunodeficiency disorders, history of chronic inflammatory&#xD;
             disorders, oral or injected steroid use in last 4 weeks;&#xD;
&#xD;
         14. Subjects who are pregnant or breast feeding;&#xD;
&#xD;
         15. Subjects who are currently involved in any injury litigation or workers compensation&#xD;
             claims;&#xD;
&#xD;
         16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this&#xD;
             study that would affect the outcomes of this study;&#xD;
&#xD;
         17. Subjects with a history of noncompliance with medical treatment, physical therapy&#xD;
             (PT)/rehabilitation, or clinical study participation&#xD;
&#xD;
         18. Subject who, in the opinion of the Investigator, has an emotional or neurological&#xD;
             condition that would pre-empt their ability or willingness to participate in the study&#xD;
             including mental illness, mental retardation, and drug or alcohol abuse;&#xD;
&#xD;
         19. Subjects who do not meet the indication or are contraindicated according to specific&#xD;
             Smith+Nephew REGENETEN System's Instructions for Use (IFUs);&#xD;
&#xD;
         20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section&#xD;
             3.44.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Peach, MBBS MD FRCS (Tr&amp;Orth)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harbin Clinic</name>
      <address>
        <city>Rome</city>
        <state>Georgia</state>
        <zip>30165</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>Sinai Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syracuse Orthopedic Specialists</name>
      <address>
        <city>DeWitt</city>
        <state>New York</state>
        <zip>13214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Orthopedic Specialists</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021-5011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist The Woodlands</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>17201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashland Memorial Medical Center</name>
      <address>
        <city>Ashland</city>
        <state>Wisconsin</state>
        <zip>54806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OrthoSport Victoria</name>
      <address>
        <city>Richmond</city>
        <state>Victoria</state>
        <zip>3121</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Orthopaedics</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2K 4X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Ambroise Paré</name>
      <address>
        <city>Paris</city>
        <state>Boulogne-Billancourt</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pasteur 2</name>
      <address>
        <city>Nice</city>
        <state>Provence-Alpes-Côte d'Azur</state>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint-Jean - Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34430</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bichat Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé de l'Ouest Parisien</name>
      <address>
        <city>Trappes</city>
        <state>Île-de-France</state>
        <zip>78190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169856</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schulthess Klinik</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Blackburn Hospital</name>
      <address>
        <city>Blackburn</city>
        <state>Lancashire</state>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of South Manchester NHS Foundation Trust</name>
      <address>
        <city>Wythenshawe</city>
        <state>Manchester</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital NHS Trust</name>
      <address>
        <city>Stanmore</city>
        <state>Middlesex</state>
        <zip>HA7 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospital</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Coventry and Warwickshire</name>
      <address>
        <city>Coventry</city>
        <state>Warwickshire</state>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Orthopaedic Hospital NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B31 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS105NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Hong Kong</country>
    <country>Singapore</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotator cuff tendon</keyword>
  <keyword>Full thickness tears</keyword>
  <keyword>REGENETEN Bioinductive Implant System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <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/NCT04450342
org study id: REGENETEN.2020.01
nct id: NCT04450342
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair
      (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair
      or revision repair versus Arthroscopic rotator cuff repair alone.
This study is a prospective, multi-center, randomized, controlled clinical study in the
      treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML
      according to Cofield classification). The subjects meeting the inclusion/exclusion criteria
      specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone.
      Subjects enrolled into the revision repair subject group will receive ARCR augmented with
      REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2
      weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome
      measures, objective measures of movement and an MRI scan to assess the integrity of the
      repair and assess the re-tear rate. Health economic data will also be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 6 months retear rate
time frame: 6 months post surgery
description: The cumulative 6 months retear rate after full-thickness ARCR augmented with REGENETEN versus ARCR alone. Failure is defined as Sugaya Type IV or V retear/recurrence (fullthickness discontinuity seen on both coronal and oblique sagittal MRI images).
measure: Retear rate
time frame: 3, 6, 12, and 24 months
description: Cumulative 3, 6, 12, and 24 months retear rate after fullthickness ARCR augmented with REGENETEN (confirmed on MRI) versus ARCR alone. Failure is defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
measure: Oxford Shoulder Score (OSS)
time frame: Baseline, 3, 6, 12 and 24 months
description: The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
measure: Western Ontario Rotator Cuff (WORC)/Chinese version WORC (C-WORC) Index)
time frame: Baseline, 3, 6, 12 and 24 months
description: The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Each question uses a visual analog scale (VAS) representing a 100-point scale ranging from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final score can also be presented as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. The total final WORC/CWORC Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
measure: Constant-Murley Score
time frame: Baseline, 3, 6, 12 and 24 months
description: The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range of 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point given per 0.5 kg of weights raised), and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder (40 points; range 0=worst, 10=best). The higher the score, the higher the quality of function.
measure: Subjective shoulder value (SSV)
time frame: Baseline, 3, 6, 12 and 24 months
description: Overall performance of full-thickness ARCR augmented with REGENETEN versus ARCR alone at Baseline and at 3, 6, 12 and 24 months assessed by the Subjective Shoulder Value (SSV). The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% (0% to 100% scale with 100% being normal).
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
time frame: Baseline, 3, 6, 12 and 24 months
description: The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas.
The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
measure: Patient satisfaction Questionnaire Outcome
time frame: Baseline, 3, 6, 12 and 24 months
description: The Patient Satisfaction Questionnaire is a simple subjective assessment of the success of surgery from the patient's perspective. Pre-Op: will be documented on a visual analogue score of 0-100. Rated by the subject with 0 is the least satisfied, 100 the most satisfied.Post-Op:This includes the VAS Patient Satisfaction Score as for pre-Op and additional five questions ask of the patient:1. How well did the surgery relieve the pain? 2. How well did the surgery increase your ability to perform regular activities? 3. How well did the surgery allow you to perform heavy work or sport activities (if allowed by Dr)? 4. How well did the surgery meet your expectations? Questions rated by the patient with excellent, very good,good, fair and poor. 5. Would you have the operation again if needed on another joint? Question rated by the patient with Definitely yes, Probably yes, Possibly not, Definitely not Rated by the subject with 0 is the least satisfied, 100 the most satisfied.
measure: Pain, Visual analog scale (VAS) Score
time frame: Baseline, 2 weeks, 6 weeks, 3 and 6 months
description: Overall performance of full-thickness ARCR augmented with REGENETEN versus ARCR alone at Baseline and at 3, 6,12 and 24 months assessed by the VAS Pain Score. Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
measure: MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Sugaya Score postoperatively
time frame: Baseline, 3, 6, 12 and 24 months
description: The Sugaya score will be used to determine postoperative cuff integrity through magnetic resonance imaging classified into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogenously low intensity. Type II indicates sufficient thickness with partial high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates presence of a minor discontinuity, suggesting a small full-thickness tear. Type V indicates the presence of a major discontinuity, suggesting a medium or large full-thickness tear.
measure: MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone via Goutallier Classification postoperatively
time frame: Baseline, 3, 6, 12 and 24 months
description: The Goutallier classification will be used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranges from a grade of 0 indicating a completely normal muscles without any fatty streaks to a grade of 4 which indicates that more fat than muscle is present.
measure: Total tendon thickness, tendon length will be assessed by MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone postoperatively
time frame: Baseline, 3, 6, 12 and 24 months
description: Tendon thickness, length will be assessed by MRI
measure: Size of retear: anteroposterior [AP]/mediolateral [ML]) postoperatively
time frame: Baseline, 3, 6, 12 and 24 months
description: Size of retear will be based on MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone.
measure: Shape of retear postoperatively
time frame: Baseline, 3, 6, 12 and 24 months
description: Shape of retear will be based on MRI Tendon Findings in ARCR augmented with REGENETEN versus ARCR alone
measure: Outcome of Return to Work Questionnaire in ARCR augmented with REGENETEN versus ARCR alone
time frame: Baseline, 2 weeks, 6 weeks, 3, 6, 12 and 24 months
description: Generic questionnaire, covering work related questions,including demographics on laborer/sedentary.
measure: Cumulative duration of opioid use in ARCR augmented with REGENETEN versus ARCR alone
time frame: 2 weeks
description: Self-reported opioid use diary completed by the patient on a daily basis, from day 0-14, documenting opioid use. Consumption daily (YES/NO) x14 days, 'Have you taken any opioid medication today for shoulder pain?' Y/N .
measure: Total operative time ARCR augmented with REGENETEN versus ARCR alone
time frame: Intra-operative time
description: Total operative time ARCR augmented with REGENETEN versus ARCR alone.
measure: Sling type and mobilization time in ARCR augmented with REGENETEN versus ARCR alone
time frame: 3 months
description: The type of sling will be collected and presented for each treatment arm summarizing if standard sling, shoulder immobilizer, abduction sling, ER sling, or other were advised and mobilization time will be calculated for both arms summarizing mobilization duration.
arm group label: ARCR augmented with REGENETEN™ Bioinductive Implant
arm group type: Experimental
description: During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
arm group label: ARCR alone
arm group type: Sham Comparator
description: The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
arm group label: ARCR revision group
arm group type: Other
description: ARCR revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
intervention type: Device
intervention name: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
description: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
arm group label: ARCR augmented with REGENETEN™ Bioinductive Implant
intervention type: Procedure
intervention name: Arthroscopic rotator cuff repair
description: The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
arm group label: ARCR alone
intervention type: Device
intervention name: Arthroscopic rotator cuff repair for revision surgery
description: The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
arm group label: ARCR revision group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Peach, MBBS MD FRCS (Tr&Orth)
role: Principal Investigator
affiliation: Manchester University NHS Foundation Trust
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country: Australia
country: Canada
country: France
country: Hong Kong
country: Singapore
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
sharing ipd: No