Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Study Overview
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Brief Summary
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The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

Detailed Description
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A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the control group will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the experimental group will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Official Title
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Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study

Conditions
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Rotator Cuff Tears, Rotator Cuff Tear Arthropathy

Intervention / Treatment
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* Procedure: arthroscopic rotator cuff repair
* Biological: Bioinductive implant
* Diagnostic Test: Ultrasound Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indicated and scheduled for arthroscopic rotator cuff repair. Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging. Chronic, degenerative rotator cuff tears. Ability to read and understand English. Age ≥18 years Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy Exclusion Criteria: Patient scheduled for open or mini-open rotator cuff repair Prior surgery of affected shoulder (except diagnostic arthroscopy) Partial-thickness rotator cuff tears Small (<1 cm) rotator cuff tears Rotator cuff tears involving the subscapularis tendon Acute and traumatic rotator cuff tears Active infection Cancer Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Patients will be randomized into one of two groups. In the control group, patients will receive the current surgical treatment for rotator cuff tears: debridement and repair. Patients in the experimental group will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in postoperative ultrasound imaging studies.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. | Procedure: arthroscopic rotator cuff repair<br>* This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.<br>Diagnostic Test: Ultrasound Imaging<br>* An ultrasound will be performed on each patient one year postoperatively.<br>|
| Experimental: Study Group<br>Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. | Procedure: arthroscopic rotator cuff repair<br>* This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.<br>Biological: Bioinductive implant<br>* A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.<br>* Other names: Bioinductive patch;Diagnostic Test: Ultrasound Imaging<br>* An ultrasound will be performed on each patient one year postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotator cuff repair integrity | absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively. | Preoperative to 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMs scores for upper extremity function | Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function. | Preoperative to 2 years postoperative | 
| PROMs scores for depression | Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse). | Preoperative to 2 years postoperative | 
| PROMs scores for upper extremity pain interference | Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse). | Preoperative to 2 years postoperative | 
| Shoulder Range of Motion | Standard range of motion values collected by the surgeon during preoperative and followup visits | Preoperative to 2 years postoperative | 
| Shoulder Strength | Standard shoulder strength values collected by the surgeon during preoperative and followup visits. Medical Research Council Manual Muscle Testing scale will be used to measure the patient's strength on a 0 to 5 scale with 0 being the minimum and 5 being the maximum. Higher scores are better/normal. | Preoperative to 2 years postoperative | 
| Complications | Both intra- and postoperative complications will be collected. | Intraoperative to 2 years postoperative | 
| Reoperation | Whether or not patients required another operation. | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tear, Bioinductive, Arthroscopic Rotator Cuff Repair, Rotator Cuff Tear Arthropathy