Smith+Nephew has reported positive data from a new randomised controlled trial (RCT) that supports the use of its Regeneten bioinductive implant in rotator cuff repair.
The Regeneten bioinductive implant offers a patient-centric therapy that supports the natural healing response of the body for rotator cuff tears.
In early studies, the implant demonstrated its ability to alter the tear progression course, facilitating return to normal activity and reducing re-tears in comparison to standard surgery.
It is said to be part of the company’s Advanced Healing Solutions portfolio.
The interim analysis from the RCT revealed a substantial decrease in the re-tear rate of full-thickness rotator cuff repairs when using the Regeneten implant.
In the multicentre, triple-blinded RCT, the re-tear rates of patients with medium to large full-thickness tears were measured after either an arthroscopic supraspinatus transosseous equivalent (TOE) repair performed alone or with a Regeneten Bioinductive Implant.
At a 12-month follow-up, the repairs with the additional REGENETEN Bioinductive Implant had less re-tear rates compared to those with a TOE repair alone.
The findings showed that patients who received a REGENETEN Bioinductive Implant had a 3.5% re-tear rate.
Patients who got only TOE repair showed a 25% re-tear rate, which is consistent with the re-tear rates reported for similar tear types in other published studies.
The company stated that there were no differences in postoperative complications observed between the groups during the trial.
Smith+Nephew Sports Medicine Joint Repair vice-president Christie Van Geffen said: “New RCT evidence supporting the use of our REGENETEN Bioinductive Implant for improved patient outcomes continues to grow.
“No other bioinductive treatment has the amount of science behind it supporting the clinical value for thousands of patients with rotator cuff tears.”