Study Results: REGENETEN Bioinductive Implant in Rotator Cuff Tear

By Julie A. Vetalice and wire services

Study Results: REGENETEN Bioinductive Implant in Rotator Cuff Tear

Smith+Nephew released study results showing that patients treated with just its REGENETEN Bioinductive Implant for partial-thickness rotator cuff tears experienced significantly improved shoulder function during early recovery compared to patients receiving a REGENETEN Implant plus traditional surgical repair, with equivalent efficacy at one year.

Study investigators compared the use of a REGENETEN Implant alone (without surgical repair) to a REGENETEN Implant plus traditional surgical repair for the treatment of partial-thickness rotator cuff tears in 227 patients across 19 U.S. surgical centers.

Key findings included:

  • Compared with traditional surgical repair, patients reported a significant improvement in shoulder function in the early post-operative period (weeks 2 and 6) with the REGENETEN Implant alone
  • Treatment with the REGENETEN Implant alone demonstrated equivalent efficacy to REGENETEN plus traditional surgical repair with minimal revisions across both treatment groups at 1 year
  • Among all patients receiving a REGENETEN Implant, patients reported significant improvements in pain, function and quality of life from at 1 year compared with pre-surgery values

Smith+Nephew's collagen-based REGENETEN Bioinductive Implant supports the body's natural healing response by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression. Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and is completely resorbed within six months.

Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.

Source: Smith+Nephew

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Trial/Study