A Phase 4 interventional study of arthroscopic rotator cuff repair and Bioinductive implant in Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 78 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Procedure: arthroscopic rotator cuff repair · Diagnostic Test: Ultrasound Imaging
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Procedure: arthroscopic rotator cuff repair · Biological: Bioinductive implant · Diagnostic Test: Ultrasound Imaging
This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
Also known as: Bioinductive patch
An ultrasound will be performed on each patient one year postoperatively.
Rotator cuff repair integrity
absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
Time frame: Preoperative to 1 year postoperative
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.
Time frame: 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).
Time frame: 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).
Time frame: Preoperative to 2 years postoperative
Shoulder Range of Motion
Standard range of motion values collected by the surgeon during preoperative and followup visits
Time frame: 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.
Time frame: Preoperative to 2 years postoperative
Complications
Both intra- and postoperative complications will be collected.
Time frame: Intraoperative to 2 years postoperative
Reoperation
Whether or not patients required another operation.
Time frame: 2 years postoperative
Plan to share: No — No IPD will be shared with other researchers.
No publications or documents are linked to this record.
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