Rotator Cuff Tears Clinical Trial
Official title:
Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Shoulder Range of Motion | Standard range of motion values collected by the surgeon during preoperative and followup visits | Preoperative to 2 years postoperative | |
Secondary | 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 | |
Secondary | Complications | Both intra- and postoperative complications will be collected. | Intraoperative to 2 years postoperative | |
Secondary | Reoperation | Whether or not patients required another operation. | 2 years postoperative |
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