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Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
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.
Study details:
The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-08-30
Primary completion: 2025-09-30
Study completion finish: 2027-06-30
Study type
TREATMENT
Phase
NA
Trial ID
NCT05444465
Intervention or treatment
DEVICE: Isolated Bioinductive Repair
PROCEDURE: Completion and Repair
Conditions
- • Rotator Cuff Injuries
Find a site
Closest Location:
OrthoSport Victoria
Research sites nearby
Select from list below to view details:
OrthoSport Victoria
Richmond, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Isolated Bioinductive Repair
| DEVICE: Isolated Bioinductive Repair
|
ACTIVE_COMPARATOR: Completion and Repair
| PROCEDURE: Completion and Repair
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in Western Ontario Rotator Cuff (WORC) | 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). | Change from baseline to 3 months post-intervention |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Western Ontario Rotator Cuff (WORC) | 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). | Pre-op, 6 weeks, 3, 6, 12 and 24 months |
Constant-Murley Score | 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. | Pre-Op, 3, 6, 12 and 24 months |
Subjective Shoulder Value (SSV) score | 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). | Pre-Op, 6 weeks, 3, 12 and 24 months |
EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS & index scores | 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. | Pre-Op, 3 and 6 weeks, 3, 6, 12 and 24 months |
Change in Western Ontario Rotator Cuff (WORC) | 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). | Change from Pre-op to 6 weeks, 3, 6, 12 and 24 months |
Change in Constant-Murley Score | 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. | Change from Pre-Op to 6 weeks, 3, 12 and 24 months |
Change in Subjective Shoulder Value (SSV) score | 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). | Change from Pre-Op to 6 weeks, 3, 12 and 24 months |
Percent Achieving Minimal Clinically Important Difference (MCID) for Constant-Murley Score | 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. | Pre-Op, 3, 6, 12 and 24 months |
Percent Achieving MCID for Western Ontario Rotator Cuff (WORC) | 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). | Pre-op, 6 weeks, 3, 6, 12 and 24 months |
Percent Achieving MCID for Subjective Shoulder Value (SSV) score | 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). | Pre-Op, 6 weeks, 3, 12 and 24 months |
Patient Satisfaction | 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. | 6 weeks, 3, 6, 12 and 24 months |
Pain, Visual analog scale (VAS) 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. | Pre-Op, 3 and 6 weeks, 3, 12 and 24 months |
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Sugaya Score | 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. | 12 months |
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of percent filling | 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%. | 12 months |
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via MRI assessment of the signal intensity pattern | 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. | 12 months |
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Rotator cuff tendon thickness | Tendon thickness will be measured in millimeters (mm). | 12 months |
MRI Tendon Findings in subjects with Isolated Bioinductive Repair versus completion via Goutallier classification | 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. | 12 months |
Incidence of Revision Surgery | Number of subjects requiring revision surgery | 1, 3 and 6 weeks, 3, 6, 12 and 24 months |
Time to return to work | Number of weeks taken to return to work following surgery | Up to 24 months |
Time to return to driving | Number of weeks taken to return to driving following surgery | Up to 24 months |
Time to return to sports | Number of weeks taken to return to sport following surgery | Up to 24 months |
Total operative time | Time expressed in minutes | Inter-operative time |
Physical Therapy Utilization | Number visits following index surgery | Up to 24 months |
Cumulative days of opioid use | 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?' | Day 1-14 |
Duration of shoulder immobilization following index surgery | Number of days | 1, 3 and 6 weeks, 3 months |
Frequently Asked Questions
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