Bioinductive Patch for Full-Thickness Rotator Cuff Tears
- Conditions
- Rotator Cuff TearsRotator Cuff Tear Arthropathy
- Interventions
- Procedure: arthroscopic rotator cuff repairDiagnostic Test: Ultrasound ImagingBiological: Bioinductive implant
- Registration Number
- NCT05439850
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group arthroscopic rotator cuff repair Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. Control Group Ultrasound Imaging Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. Study Group Ultrasound Imaging Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. Control Group arthroscopic rotator cuff repair Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. Study Group Bioinductive implant Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
- Primary Outcome Measures
Name Time Method Rotator cuff repair integrity Preoperative to 1 year postoperative absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
- Secondary Outcome Measures
Name Time Method Reoperation 2 years postoperative Whether or not patients required another operation.
PROMs scores for upper extremity function Preoperative to 2 years postoperative 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.
PROMs scores for upper extremity pain interference Preoperative to 2 years postoperative 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).
Shoulder Range of Motion Preoperative to 2 years postoperative Standard range of motion values collected by the surgeon during preoperative and followup visits
PROMs scores for depression Preoperative to 2 years postoperative 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).
Shoulder Strength Preoperative to 2 years postoperative 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.
Complications Intraoperative to 2 years postoperative Both intra- and postoperative complications will be collected.
Trial Locations
- Locations (1)
Henry Ford Health
🇺🇸Detroit, Michigan, United States