Study backs Smith+Nephew Regeneten bioinductive rotator cuff implant
11 Jan 2024
Clinical Result
Data published online in Arthroscopy highlighted the success of Regeneten against the standard of care. One-year results found that medium and large full-thickness rotator cuff tears repaired and augmented with the implant had better tendon healing.
Regeneten provides a patient-centric treatment supporting the body’s natural healing process, according to S+N. The aim is for the collagen-based implant to change the course of tear progression, aid return to normal activity and reduce re-tears compared to conventional surgery. Smith+Nephew previously reported positive data on the implant in September 2022.
About the data from Smith+Nephew
Results included a significantly lower re-tear rate, at 8.3% with Regeneten against 25.8% with the standard of care. The implant also had a three-times lower risk of re-tear and no difference in the number of serious or minor complications.
The blinded, multi-center trial compared the healing rate of the tears with and without augmentation with Regeneten. In total, 124 patients with repairable medium and large full-thickness posterosuperior rotator cuff tears were randomized to receive either an arthroscopic transosseous equivalent double-row rotator cuff repair or the same repair augmented with Regeneten.
Dr. Miguel Ruiz Ibán, the study’s principal investigator, said the trial showed substantial, significant reduction in re-tear risk. The head of the shoulder and elbow unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, said data supports the use of the implants to reduce re-tear rates in the studied population.
“Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the Regeneten bioinductive implant,” said Christie Van Geffen, SVP sports medicine global marketing at Smith+Nephew. “Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.”
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