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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05444465
Registration number
NCT05444465
Ethics application status
Date submitted
29/06/2022
Date registered
6/07/2022
Titles & IDs
Public title
Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
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Scientific title
Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
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Secondary ID [1]
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REGENETEN.2021.04
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Universal Trial Number (UTN)
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Trial acronym
IMPACT
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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 - Isolated Bioinductive Repair
Treatment: Surgery - Completion and Repair
Experimental: Isolated Bioinductive Repair - Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
Active comparator: Completion and Repair - Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.
Treatment: Devices: Isolated Bioinductive Repair
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
Treatment: Surgery: Completion and Repair
Standard surgical repair using the 'Completion and Repair' technique.
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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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Change in Western Ontario Rotator Cuff (WORC)
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Assessment method [1]
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The 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 Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
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Timepoint [1]
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Change from baseline to 3 months post-intervention
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Secondary outcome [1]
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Western Ontario Rotator Cuff (WORC)
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Assessment method [1]
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The 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 Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
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Timepoint [1]
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Pre-op, 6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [2]
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Constant-Murley Score
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Assessment method [2]
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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 (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.
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Timepoint [2]
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Pre-Op, 3, 6, 12 and 24 months
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Secondary outcome [3]
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Subjective Shoulder Value (SSV) score
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Assessment method [3]
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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).
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Timepoint [3]
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Pre-Op, 6 weeks, 3, 12 and 24 months
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Secondary outcome [4]
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores
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Assessment method [4]
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To assess the subject's health state. The EQ-5D-5L is composed of the EQ- 5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS).
The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ- 5D-5L profile.
The EQ VAS corresponds to a 20 cm vertical, visual analogue scale ranging from 'the best health you can imagine' to 'the worst health you can imagine'.
A higher number is a better outcome.
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Timepoint [4]
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Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [5]
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Change in Western Ontario Rotator Cuff (WORC)
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Assessment method [5]
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The 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 Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
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Timepoint [5]
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Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [6]
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Change in Constant-Murley Score
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Assessment method [6]
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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 (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.
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Timepoint [6]
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Change from Pre-Op to 6 weeks, 3, 12 and 24 months
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Secondary outcome [7]
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Change in Subjective Shoulder Value (SSV) score
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Assessment method [7]
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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).
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Timepoint [7]
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Change from Pre-Op to 6 weeks, 3, 12 and 24 months
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Secondary outcome [8]
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Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score
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Assessment method [8]
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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 (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.
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Timepoint [8]
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Pre-Op, 3, 6, 12 and 24 months
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Secondary outcome [9]
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Percent Achieving MCID for Western Ontario Rotator Cuff (WORC)
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Assessment method [9]
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The 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 Index scores can, therefore, range from 0% (lowest functional status level) to 100% (highest functional status level).
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Timepoint [9]
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Pre-op, 6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [10]
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Percent Achieving MCID for Subjective Shoulder Value (SSV) score
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Assessment method [10]
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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).
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Timepoint [10]
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Pre-Op, 6 weeks, 3, 12 and 24 months
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Secondary outcome [11]
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Patient Satisfaction
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Assessment method [11]
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Comprise of 2 questions:
1. Overall, I am satisfied with the outcome of my surgery
2. I would recommend the procedure to a friend.
Question rated by the patient with Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree.
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Timepoint [11]
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6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [12]
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Pain, Visual analog scale (VAS) Score
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Assessment method [12]
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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.
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Timepoint [12]
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Pre-Op, 3 and 6 weeks, 3, 12 and 24 months
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Secondary outcome [13]
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score
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Assessment method [13]
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The Sugaya score is 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.
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Timepoint [13]
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12 months
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Secondary outcome [14]
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling
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Assessment method [14]
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Percent tissue infil is graded at site of original tear and classified as 0% to \< 25%, 25% to \< 50%, 50% to \< 75%, 75% to \< 100% and 100%.
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Timepoint [14]
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12 months
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Secondary outcome [15]
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern
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Assessment method [15]
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The Signal Intensity Pattern will be graded into 3 categories. Type I: Heterogeneous high signal intensity with fluid-like bright foci, Type II: Heterogeneous high signal intensity without fluid-like bright foci, Type III: Heterogeneous or homogeneous low signal intensity.
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Timepoint [15]
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12 months
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Secondary outcome [16]
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness
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Assessment method [16]
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Tendon thickness will be measured in millimeters (mm).
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Timepoint [16]
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12 months
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Secondary outcome [17]
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MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification
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Assessment method [17]
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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.
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Timepoint [17]
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12 months
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Secondary outcome [18]
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Incidence of Revision Surgery
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Assessment method [18]
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Number of subjects requiring revision surgery
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Timepoint [18]
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1, 3 and 6 weeks, 3, 6, 12 and 24 months
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Secondary outcome [19]
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Time to return to work
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Assessment method [19]
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Number of weeks taken to return to work following surgery
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Timepoint [19]
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Up to 24 months
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Secondary outcome [20]
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Time to return to driving
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Assessment method [20]
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Number of weeks taken to return to driving following surgery
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Timepoint [20]
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Up to 24 months
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Secondary outcome [21]
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Time to return to sports
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Assessment method [21]
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Number of weeks taken to return to sport following surgery
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Timepoint [21]
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Up to 24 months
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Secondary outcome [22]
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Total operative time
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Assessment method [22]
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Time expressed in minutes
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Timepoint [22]
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Inter-operative time
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Secondary outcome [23]
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Physical Therapy Utilization
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Assessment method [23]
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Number visits following index surgery
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Timepoint [23]
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Up to 24 months
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Secondary outcome [24]
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Cumulative days of opioid use
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Assessment method [24]
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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?'
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Timepoint [24]
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Day 1-14
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Secondary outcome [25]
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Duration of shoulder immobilization following index surgery
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Assessment method [25]
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Number of days
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Timepoint [25]
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1, 3 and 6 weeks, 3 months
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Eligibility
Key inclusion criteria
* The subject must provide written informed consent.
* Subject is > eighteen (18) years of age (no upper limit).
* Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
* Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
* Subject willing and able to make all required study visits.
* Subject able to follow instructions and deemed capable of completing all study questionnaires.
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Minimum age
18
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
* Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
* Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
* Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
* Subjects with current or prior infection of the ipsilateral shoulder.
* Subjects with known hypersensitivity to bovine-derived materials.
* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)).
* Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE).
* Subjects with a planned surgery on the contra-lateral shoulder within the study period.
* Systemic steroid use (oral, IV) or local steroid injection within 3 months of the date of surgery.
* Subjects with a full thickness rotator cuff tear.
* Subjects with a subscapularis tear requiring repair.
* Subjects requiring a concomitant labral fixation procedure, concomitant surgery for bone defects requiring bone implantation or for superior labral tear from anterior to posterior (SLAP).
* Subjects requiring a concomitant os acromiale fixation procedure.
* Subjects with glenohumeral joint instability (multiple dislocations/subluxations).
* Subjects with condition(s) that contraindicate or complicate outcomes of Isolated Bioinductive Repair or completion and repair 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.
* Subjects with neurologic conditions effecting either upper extremity.
* Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications.
* Subjects who are pregnant or breast feeding.
* Subjects who are currently involved in any injury litigation relating to the index shoulder.
* Subjects with current workers compensation claim.
* Subjects who are enrolled, or plan to enroll, in another clinical trial during this study that would affect the outcomes of this study.
* Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.
* 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.
* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs).
* Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
* Subjects who have participated previously in this clinical trial and who have healed or been withdrawn
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
30/08/2022
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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
30/06/2027
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Actual
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Sample size
Target
156
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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OrthoSport Victoria - Richmond
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Recruitment postcode(s) [1]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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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
Ohio
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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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
Alberta
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Country [9]
0
0
Canada
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State/province [9]
0
0
Manitoba
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Country [10]
0
0
Canada
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State/province [10]
0
0
Ontario
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Country [11]
0
0
Italy
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State/province [11]
0
0
Milano
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Country [12]
0
0
Italy
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State/province [12]
0
0
Roma
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Country [13]
0
0
Spain
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State/province [13]
0
0
Madrid
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Country [14]
0
0
United Kingdom
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State/province [14]
0
0
Surrey
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Country [15]
0
0
United Kingdom
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State/province [15]
0
0
Bath
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Country [16]
0
0
United Kingdom
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State/province [16]
0
0
Bristol
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Country [17]
0
0
United Kingdom
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State/province [17]
0
0
Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
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Trial website
https://clinicaltrials.gov/study/NCT05444465
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Laura Mills
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Address
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Smith & Nephew, Inc.
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Judith Horner
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Address
0
0
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Country
0
0
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Phone
0
0
+44 (0) 1482673251
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05444465