Clinical Information, Post-Market Clinical Study
- A prospective single-arm post market multi-center study conducted in three leading centers in the US, included 32 patients:
- Male/Female, Age range 44y-80y.
- Primary RCR and Revision Surgeries.
- Left and Right Shoulder.
- Small, Medium, Large and Massive Tears.
- 1cm< to >5cm, Partial-to Full-thickness Tears.
- 1, 2 and 3 Tunnels, (equivalent of 2, 4 or 6 anchors, respectively).
- Up to 4 sutures per tunnel.
The study showed excellent clinical outcome and high patients’ satisfaction:
OmniCuff’s users feedback:
“Overall, the MinInvasive OmniCuff transosseous rotator cuff repair system demonstrated significantly improved outcomes for treated patients. Patients were overall very satisfied with the outcome of their surgery and their ASES and SST scores demonstrated this appropriately.
Complication rates on both the major and minor scale were comparable to data in the literature. We were satisfied with the use of the system for our patient care both on a technical level as well as a patient outcome level.
The OmniCuff system is an easy to use, reliable and fairly intuitive device”