Rotator cuff repair with ActivBraid collagen co-braid suture
Official title: Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
Run by The Cleveland Clinic · NCT06971497 · Data updated 2026-11-12
We will test whether using the ActivBraid collagen co-braid suture during primary arthroscopic rotator cuff repair in adults improves tendon healing, shoulder motion, strength, and patient-reported outcomes over 6 months to 2 years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | August 11, 2025 |
| Main results expected | August 2029 |
| Study ends | August 2029 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT06971497 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 having a primary arthroscopic repair for a reparable 1–5 cm full-thickness tear of the supraspinatus and/or infraspinatus without prior ipsilateral shoulder surgery are ideal candidates.
✕Probably not a fit
Patients with prior ipsilateral shoulder surgery, isolated subscapularis tears, frozen shoulder, advanced glenohumeral arthritis, symptomatic cervical spine disease, or known hypersensitivity to bovine-derived materials are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll up to 65 adults undergoing primary arthroscopic rotator cuff repair using the ActivBraid collagen co-braid suture and follow them at 6 months, 1 year, and 2 years. Outcomes include imaging-confirmed tendon healing as well as shoulder range of motion, strength testing, and patient-reported outcome measures. Eligible patients are 18–75 years with a reparable 1–5 cm full-thickness supraspinatus and/or infraspinatus tear, and key exclusions include prior ipsilateral shoulder surgery, frozen shoulder, advanced glenohumeral arthritis, and bovine material hypersensitivity. The study is sponsored by the Cleveland Clinic in collaboration with Zimmer Biomet and collects real-world postoperative data without experimental surgical procedures beyond standard repair using ActivBraid.
Why it matters
Potential benefit: If successful, this could lead to improved tendon healing and better shoulder function after rotator cuff repair.
How similar studies have gone: Similar approaches using collagen-coated sutures and biologic augmentation have some precedent but have shown mixed results, so the benefit is not yet definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years * acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons Exclusion Criteria: * prior ipsilateral shoulder surgery * outstanding worker's compensation claim * symptomatic cervical spine disease * a frozen shoulder * advanced glenohumeral arthritis * isolated subscapularis tear * significant radiation exposure for other medical reasons. * known is advance to be claustrophobic * known history of hypersensitivity to bovine-derived materials.
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Kathleen Derwin, PhD — The Cleveland Clinic
- Study coordinator: Kathleen Derwin, PhD
- Email: derwink@ccf.org
- Phone: 216-408-7930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.