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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year. |
|
| Study Group | Experimental | Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroscopic rotator cuff repair | Procedure | This procedure is the standard of care for rotator cuff tears who fail conservative treatment options. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johnny Kasto, MD | Contact | 313-244-8078 | jkasto1@hfhs.org | |
| Stephanie J Muh, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie J Muh, MC | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
No IPD will be shared with other researchers.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
| Bioinductive implant | Biological | A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery. |
|
|
| Ultrasound Imaging | Diagnostic Test | An ultrasound will be performed on each patient one year postoperatively. |
|
| 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 |
| D002805 |
| Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |