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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04450342
Registration number
NCT04450342
Ethics application status
Date submitted
24/06/2020
Date registered
29/06/2020
Date last updated
23/05/2025
Titles & IDs
Public title
REGENETEN™ Bioinductive Implant System in Full-thickness Tears
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Scientific 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
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Secondary ID [1]
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REGENETEN.2020.01
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Universal Trial Number (UTN)
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Trial acronym
REGENETEN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Injuries
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
Treatment: Surgery - Arthroscopic rotator cuff repair
Treatment: Devices - Arthroscopic rotator cuff repair for revision surgery
Experimental: ARCR augmented with REGENETEN™ Bioinductive Implant - During the ARCR procedure, the REGENETEN™ Bioinductive Implant is covering the tendon and attached to the bone and the tendon with small anchors.
Sham comparator: ARCR alone - The rotator cuff is repaired during arthroscopic standard procedure. No product is added for healing
Other: Revision group - Revision group allows treatment of subjects having recurrent tears, ARCR supplemented with REGENETEN
Treatment: Devices: Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation
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.
Treatment: Surgery: Arthroscopic rotator cuff repair
The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
Treatment: Devices: Arthroscopic rotator cuff repair for revision surgery
The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Retear Rate at 6 Months
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Assessment method [1]
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Retear rate was measured by the percentage of retears 6 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Number of Retears at 3 Months, 12 Months, and 24 Months
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Assessment method [1]
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Number of participants with retears present 3 months, 12 months, and 24 months after full-thickness arthroscopic rotator cuff repair (ARCR) surgery. Retear was defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
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Timepoint [1]
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3 months, 12 months, and 24 months
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Secondary outcome [2]
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Oxford Shoulder Score (OSS)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [3]
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Western Ontario Rotator Cuff (WORC) / Chinese Version WORC (C-WORC) Index
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Assessment method [3]
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The WORC/C-WORC Index is self-administered, and includes a 5 different domains (physical symptoms, sports and recreation, work, social function, and emotions). Scores range from 0 to 2100 with 0 indicating no symptoms at all and 2100 indicating the worst possible symptoms (i.e., a lower score is a better outcome).
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Timepoint [3]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [4]
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Constant-Murley Score
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Assessment method [4]
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The Constant-Murley Score is a validated assessment of pain and shoulder functionality. The Constant Score is divided into 4 subscales: pain, activities of daily living, strength, and range of motion - forward flexion, external rotation, abduction and internal rotation of the shoulder. Scores range from 0 to 100 with a higher score indicating better shoulder function (i.e., a high score is a better outcome).
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Timepoint [4]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [5]
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Subjective Shoulder Value (SSV)
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Assessment method [5]
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The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder. The SSV ranges from 0 to 100, with a higher score indicating a better outcome.
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Timepoint [5]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [6]
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
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Assessment method [6]
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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 participant's health state and consists of five dimensions to create an index score for 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 participant is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The index score ranges from 0 to 1, with a higher score indicating a better outcome.
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Timepoint [6]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [7]
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
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Assessment method [7]
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The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS score is the participant's self-rated health on a vertical visual analogue scale that ranges from 0 to 100 with 100 representing the best health imaginable and 0 indicating the worst (i.e., a higher score is a better outcome).
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Timepoint [7]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [8]
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Patient Satisfaction Questionnaire: Medical Care
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Assessment method [8]
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The Patient Satisfaction Questionnaire was a simple subjective assessment from the patient's perspective for the question "How satisfied are you with your medical care?". Scores ranged from 0 to 100 with 0 indicating the least satisfied and 100 indicating the most satisfied.
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Timepoint [8]
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Baseline, 3 months, 6 months, 12 months and 24 months
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Secondary outcome [9]
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Patient Satisfaction Questionnaire: How Well Did the Surgery Relieve the Pain
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Assessment method [9]
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The post-operative Patient Satisfaction Questionnaire for pain relief was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery relieve the pain?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
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Timepoint [9]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [10]
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Patient Satisfaction Questionnaire: How Well Did the Surgery Improve Your Ability to Perform Regular Activities
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Assessment method [10]
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The post-operative Patient Satisfaction Questionnaire for ability to perform regular activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery improve your ability to perform regular activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
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Timepoint [10]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [11]
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Patient Satisfaction Questionnaire: How Well Did the Surgery Allow You to Perform Heavy Work or Sport Activities
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Assessment method [11]
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The post-operative Patient Satisfaction Questionnaire for performing heavy work or sport activities was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery allow you to perform heavy work or sport activities?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
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Timepoint [11]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [12]
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Patient Satisfaction Questionnaire: How Well Did the Surgery Meet Your Expectations
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Assessment method [12]
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The post-operative Patient Satisfaction Questionnaire for surgery expectations was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "How well did the surgery meet your expectations?" with one of the following responses: * Excellent * Very Good * Good * Fair * Poor
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Timepoint [12]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [13]
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Patient Satisfaction Questionnaire: Would You Have the Operation Again if Needed on Another Joint
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Assessment method [13]
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The post-operative Patient Satisfaction Questionnaire for having the operation again on another joint was a simple subjective assessment from the patient's perspective at 3, 6, 12, and 24 months. Participants were asked to answer, "Would you repeat the operation again if needed on another joint?" with one of the following responses: * Definitely Yes * Probably Yes * Possibly Not * Definitely Not
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Timepoint [13]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [14]
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Pain - Visual Analog Scale (VAS) Score
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Assessment method [14]
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Pain was measured using a 100-point Visual Analog Scale (VAS) score with a range from 0 to 100 where zero (0) represented no pain and 100 represented the worst pain imaginable (i.e., a lower score was a better outcome).
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Timepoint [14]
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2 weeks, 6 weeks, 3 months and 6 months
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Secondary outcome [15]
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MRI Tendon Findings: Supraspinatus Sugaya Score
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Assessment method [15]
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The Sugaya Score was used to determine postoperative cuff integrity of the supraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated 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.
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Timepoint [15]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [16]
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MRI Tendon Findings: Infraspinatus Sugaya Score
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Assessment method [16]
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The Sugaya Score was used to determine postoperative cuff integrity of the infraspinatus tendon through magnetic resonance imaging (MRI). Participants were classified as Type I, Type II, Type III, Type IV, Type V, or Indeterminate. Type I indicated 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.
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Timepoint [16]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [17]
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MRI Tendon Findings: Supraspinatus Goutallier Classification
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Assessment method [17]
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Goutallier grading for the supraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
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Timepoint [17]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [18]
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MRI Tendon Findings: Infraspinatus Goutallier Classification
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Assessment method [18]
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Goutallier grading for the infraspinatus tendon was used to classify the fatty infiltration of the rotator cuff. The Goutallier classification ranged from Grade 0 to Grade 4. Grade 0 indicated a completely normal muscle without any fatty streaks. Grade I indicated some fatty streaks. Grade 2 indicated increased fatty infiltration, but more muscle than fat. Grade 3 indicated equal amounts of fat and muscle. Grade 4 indicated more fat than muscle was present. Participants were classified as one of the following: * Grade 0 * Grade I * Grade 2 * Grade 3 * Grade 4 * Unable to assess
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Timepoint [18]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [19]
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Total Tendon Thickness
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Assessment method [19]
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Post-operative tendon thickness in millimeters (mm) taken from magnetic resonance imaging (MRI).
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Timepoint [19]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [20]
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Total Tendon Length
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Assessment method [20]
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Post-operative tendon length in millimeters (mm) taken from magnetic resonance imaging (MRI).
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Timepoint [20]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [21]
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Size of Retear: Area (Anteroposterior [AP] / Mediolateral [ML])
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Assessment method [21]
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Area of retear in millimeters squared (mm\^2) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
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Timepoint [21]
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Day 0, 3 months and 6 months
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Secondary outcome [22]
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Size of Retear: Anteroposterior (AP) Length
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Assessment method [22]
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Anteroposterior (AP) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
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Timepoint [22]
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Day 0, 3 months and 6 months
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Secondary outcome [23]
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Size of Retear: Mediolateral (ML) Length
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Assessment method [23]
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Mediolateral (ML) length of retear in millimeters (mm) at operation day (Day 0), 3 months, and 6 months taken from magnetic resonance imaging (MRI).
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Timepoint [23]
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Day 0, 3 months and 6 months
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Secondary outcome [24]
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Shape of Retear: Operative Visit
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Assessment method [24]
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Shape of tear at operative visit (Day 0) from magnetic resonance imaging (MRI) for those with re-tear at 6 months. Participants were categorized as one of the following tear shapes: * Crescent * L Shape * Reverse L * U Shape * Massive/Contracted * Unable to Determine
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Timepoint [24]
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Day 0
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Secondary outcome [25]
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Shape of Retear: 3 Months, 6 Months, 12 Months, and 24 Months
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Assessment method [25]
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Shape of retear post-operatively at 3 months, 6 months, 12 months and 24 months from magnetic resonance imaging (MRI). Participants were categorized as one of the following retear shapes: * Intact (i.e., no re-tear) * Crescent * Longitudinal * Massive * Unable to Determine
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Timepoint [25]
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3 months, 6 months, 12 months and 24 months
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Secondary outcome [26]
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Return to Work Questionnaire
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Assessment method [26]
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Generic questionnaire at 2 weeks, 6 weeks, 3 months, and 6 months with Yes/No responses for the following questions: * Returned to work? * Have you been able to return to the job you did before your surgery? * Did you feel ready to go back to work physically? * Since returning to work, any time off due to shoulder pain or weakness? * Since last follow-up visit did you take additional time off due to shoulder pain/weakness?
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Timepoint [26]
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2 weeks, 6 weeks, 3 months and 6 months
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Secondary outcome [27]
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Return to Work Questionnaire: Reason for Not Getting Back to Work
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Assessment method [27]
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The reason for not getting back to work was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Returned to work?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
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Timepoint [27]
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2 weeks, 6 weeks, 3 months, 6 months
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Secondary outcome [28]
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Return to Work Questionnaire: Reason Couldn't Return to Activities
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Assessment method [28]
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The reason for not returning to the same activities was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'No' response to the "Have you been able to return to the job you did before your surgery?" question were asked to provide a reason for not getting back to work from one of the following options: * Physical capability * Safety * Motivation * Other
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Timepoint [28]
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2 weeks, 6 weeks, 3 months, 6 months
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Secondary outcome [29]
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Return to Work Questionnaire: Time Off
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Assessment method [29]
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Number of days taken off after returning to work because of shoulder pain or weakness was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Since returning to work, any time off due to shoulder pain or weakness?" question were asked to provide how long they have taken off in days.
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Timepoint [29]
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2 weeks, 6 weeks, 3 months, 6 months
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Secondary outcome [30]
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Return to Work Questionnaire: Duration Away From Work (Days)
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Assessment method [30]
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Number of days taken away from work following surgery was a conditional question asked from the Return to Work Questionnaire. Only participants with a 'Yes' response to the "Returned to work?" question were asked to provide the number of days taken away from work
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Timepoint [30]
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2 weeks, 6 weeks, 3 months, 6 months
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Secondary outcome [31]
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Duration of Opioid Use
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Assessment method [31]
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Duration of opioid use in days up to 14 days post-surgery was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
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Timepoint [31]
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Following surgery, up to 14 days
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Secondary outcome [32]
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Opioid Use for More Than 5 Days Post-Surgery
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Assessment method [32]
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Number of participants taking opioids for more than 5 days post-surgery (Yes/No) was based on self-reported opioid use diary completed by the patient on a daily basis for 2 weeks after surgery.
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Timepoint [32]
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Following surgery, up to 14 days
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Secondary outcome [33]
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Total Operative Time
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Assessment method [33]
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Total operative time in minutes.
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Timepoint [33]
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Intraoperative
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Secondary outcome [34]
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Sling Type
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Assessment method [34]
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The type of sling used up to 3 months post-surgery for each participant was categorized as one of the following: * Standard Sling * Shoulder Immobilizer * Sling and Swathe * Abduction Sling * External Rotation Sling * Other * Missing
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Timepoint [34]
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up to 3 months
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Secondary outcome [35]
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Mobilization Time in Sling
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Assessment method [35]
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Mobilization time was the duration, measured in weeks, that participants spent in a sling.
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Timepoint [35]
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up to 3 months
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Eligibility
Key inclusion criteria
1. Subject requires Arthroscopic rotator cuff repair (ARCR);
2. Subjects with a diagnosis of a symptomatic primary or recurrent (revision repair subject group), large or massive tear (= 3 cm AP/ML) of the supraspinatus and/or infraspinatus tendons amenable to repair. For screening purposes, a = 2 cm AP/ML tear as measured on MRI will be eligible to proceed to the operative visit but will have to be confirmed as = 3 cm on arthroscopy using a calibrated probe to proceed;
3. Subject is > 40 years of age (no upper limit);
4. Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) / Institutional Review Board (IRB) approved consent form;
5. Subject is willing and able to participate in required follow-up visits and is able to complete study activities.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;
2. Subjects with Samilson-Prieto osteoarthritis > 2;
3. Subjects with current or prior infection of the ipsilateral shoulder;
4. Subjects with known hypersensitivity to bovine-derived materials;
5. Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;
6. Subjects with prior shoulder surgery (not including rotator cuff repair [revision repair subject group only], biceps tenodesis/tenotomy, distal clavicle excision [DCE], subacromial decompression);
7. Subjects with an irreparable or partially reparable rotator cuff tear;
8. Subjects with a subscapularis tear requiring repair;
9. Subjects requiring a concomitant labral fixation procedure;
10. Subjects requiring a concomitant os acromiale fixation procedure;
11. Subjects with glenohumeral joint instability (multiple dislocations/subluxations);
12. Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;
13. Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., > Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;
14. Subjects who are pregnant or breast feeding;
15. Subjects who are currently involved in any injury litigation or workers compensation claims;
16. Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study;
17. Subjects with a history of noncompliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation
18. Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, and drug or alcohol abuse;
19. Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
20. Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/10/2023
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Sample size
Target
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Accrual to date
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Final
119
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
Macquarie University Hospital - Sydney
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Recruitment hospital [2]
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OrthoSport Victoria - Richmond
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Recruitment postcode(s) [1]
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2109 - Sydney
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Recruitment postcode(s) [2]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Georgia
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Illinois
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Maryland
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Ohio
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Texas
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Wisconsin
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Country [8]
0
0
Canada
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State/province [8]
0
0
New Brunswick
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Country [9]
0
0
Canada
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State/province [9]
0
0
Ontario
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Country [10]
0
0
France
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State/province [10]
0
0
Boulogne-Billancourt
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Country [11]
0
0
France
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State/province [11]
0
0
Provence-Alpes-Côte d'Azur
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Country [12]
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France
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Montpellier
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France
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Paris
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France
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Île-de-France
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Hong Kong
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Hong Kong
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Singapore
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Zurich
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United Kingdom
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Lancashire
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United Kingdom
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Manchester
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United Kingdom
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Merseyside
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United Kingdom
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Middlesex
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Warwickshire
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United Kingdom
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West Midlands
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United Kingdom
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04450342
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Chris Peach, MBBS MD FRCS (Tr&Orth)
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Manchester University NHS Foundation Trust
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/42/NCT04450342/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/42/NCT04450342/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04450342
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