London-based Smith+Nephew designed Regeneten to provide a patient-centric treatment supporting the body’s natural healing process. The aim is for the implant to change the course of tear progression, aid return to normal activity and reduce re-tears compared to conventional surgery.
Interim analysis from a randomized controlled trial showed a significant reduction in the re-tear rate of full-thickness rotator cuff repairs when using Regeneten, according to a news release. Re-tear rates of patients with medium to large full-thickness tears were measured following either an arthroscopic supraspinatus transosseous equivalent (TOE) repair alone, or the same TOE repair with the addition of a Regeneten implant.
Dr. Miguel Angel Ruiz-Ibán of Hospital Universitario Ramon Y Cajal, Madrid, Spain, presented results at the 2022 SECEC-ESSE Congress in Dublin, Ireland.
“Traditional rotator cuff procedures and the resulting re-tear rates present a challenge and a concern for both surgeons and patients alike,” said Dr. Ruiz-Ibán. “The interim results from this RCT are encouraging and indicate that the Smith+Nephew Regeneten bioinductive implant may significantly improve re-tear rates. I look forward to the completion of this investigation in 2023 and further use of the implant.”
Smith+Nephew reports positive re-tear rate results
At 12-month follow-up, patients who received a Regeneten implant had a re-tear rate of 3.5%. Patients who received a TOE repair alone had a re-tear rate of 25%. That rate is in line with published rates on similar tear types, Smith+Nephew said. The study observed no differences in postoperative complications between groups.
“New RCT evidence supporting the use of our Regeneten bioinductive implant for improved patient outcomes continues to grow,” said Christie Van Geffen, VP sports medicine joint repair at Smith+Nephew. “No other bioinductive treatment has the amount of science behind it supporting the clinical value for thousands of patients with rotator cuff tears.”