Clinical Study Overview
A clinical trial was conducted in Sydney, Australia to demonstrate tissue induction and safety of the Rotation Medical Rotator Cuff Repair System. The study enrolled 30 patients who required rotator cuff surgery (conservative treatment was not successful) in a prospective, multi-center (5 hospitals), non-randomized trial.
Twenty-four patients with partial- or full-thickness supraspinatus tendon tears underwent arthroscopic subacromial decompression (ASD) followed by implantation of the Rotation Medical bioinductive implant:
- 15 patients had ASD only, without cuff repair, prior to implantation of the device
- 9 patients had ASD plus traditional cuff repair prior to implantation of the device
Six additional patients with partial-thickness supraspinatus tendon tears underwent ASD but did not receive the implant (controls).
ASD-only patients, with or without the implant, had the standard ASD rehabilitation protocol (less than 2 weeks in sling). Repair patients had standard rehabilitation protocol for rotator cuff repair (6 weeks in sling).
The MRI observations in humans were consistent with the histological results from prior sheep studies.
- No adverse reactions to the implant
- The Rotation Medical Bioinductive Implant consistently induced the formation of new tendinous tissue
- The average increase in tendon thickness was 2.4 mm (64%)
- The new tissue was well-integrated with the host tissues at the bone interface and along the length of the tendon
- The new tissue showed progressive maturation
- Consistent improvement in clinical scores