Smith+Nephew already has data showing its regenerative implant for rotator cuff surgery can help foster the growth of new, tendon-like tissues. Now, a randomized trial has shown those repairs can be strong enough to last for a year.
The blinded study’s results demonstrated an 86% reduction in the number of subsequent rotator cuff tears within 12 months among people who had suffered a full-thickness injury, or the complete disconnection of the tendon from the bones in the shoulder joint.
The postage stamp-sized Regeneten implant—designed to trigger the tissue’s healing response and be fully absorbed by the body in about six months—is placed across the tear through a small incision during an arthroscopic repair procedure. The study compared the same operation with and without the addition of the implant.
After one year, people who received Regeneten saw re-tears in their rotator cuff in 3.5% of cases. Patients who underwent the procedure alone had a rate of 25%.
In addition, there were no differences in post-op complications between the two groups, according to a press release. The ongoing study is slated to continue into 2023. Its interim results were presented at the annual meeting of the European Society for Surgery of the Shoulder and the Elbow in Dublin, Ireland.
Regeneten’s bioinductive approach is also being explored for hip injuries and Achilles tendon tears in the ankle. Previously cleared by the FDA in 2014, Smith+Nephew acquired the collagen-based rotator cuff implant through its $210 million purchase of Rotation Medical in 2017.
The company estimates that Regeneten could be employed in about 545,000 rotator cuff procedures annually across the globe. A previous study in patients with partial-thickness tears showed that after two years, the regrown tissue was “radiologically indistinguishable” from the treated tendons, and MRI scans showed no worsening in the tears.