Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Study Overview
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Brief Summary
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Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery. Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed. The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.

Official Title
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Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.

Conditions
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Rotator Cuff Tears, Shoulder Surgery

Intervention / Treatment
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* Device: Regeneten Collagen Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability . Symptoms > 3 months Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility) Exclusion Criteria: Revision surgery Cervical pathology Adhesive capsulitis Multi-tendon tears Concomitant upper limb pathology (eg: arthritis, nerve compression) Infection Previous fracture Instability Pregnancy and lactation Professional athlete Worker's compensation or compensable claim Substance abuse or current mental illness Smoker Adverse reaction to bovine derived products

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Partial Rotator Cuff Repair<br>Routine partial rotator cuff repair | |
| Active Comparator: Partial Rotator Cuff Repair with Regeneten Scaffold<br>Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch | Device: Regeneten Collagen Patch<br>* Partial rotator cuff repair surgery with the addition of the Regeneten scaffold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotator Cuff Healing | The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months) | 24 months | 
| Participant Satisfaction: ASES assessment | Participant Satisfaction with their surgical outcomes will be measured with the use of the American Shoulder and Elbow Surgeons at 6 week, 3-, 6-, 12- and 24 months after surgery | 24 months | 
| Participant Satisfaction: WORC assessment | Participant Satisfaction with their surgical outcomes will be measured with the use of the Western Ontario Rotator Cuff Index at 6 week, 3-, 6-, 12- and 24 months after surgery | 24 months | 
| Participant Satisfaction: SANE assessment | Participant Satisfaction with their surgical outcomes will be measured with the use of the Single Assessment Numeric Evaluation at 6 week, 3-, 6-, 12- and 24 months after surgery | 24 months | 
| Participant Satisfaction: VR-12 assessment | Participant Satisfaction with their surgical outcomes will be measured with the use of the Veteran's Rand 12 assessment at 6 week, 3-, 6-, 12- and 24 months after surgery | 24 months | 
| Participant Satisfaction: GRC assessment | Participant Satisfaction with their surgical outcomes will be measured with the use of the Global Rating of Change scale at 6 week, 3-, 6-, 12- and 24 months after surgery | 24 months |