Retear remains the main problem after rotator cuff repair, and the Regeneten bioinductive collagen implant is marketed to improve healing. This systematic review pooled 17 studies covering 1062 tears (966 treated with Regeneten) to assess retear rates, imaging, clinical scores, and cost. It asks whether adding this implant actually improves outcomes over conventional repair.
When you weigh a biological augment for rotator cuff repair, separate two questions: does it heal the tendon, and does the patient feel better? For Regeneten the answer splits. Retear rates dropped in some studies and one RCT, and MRI showed real new tissue by 6 months, but clinical scores and MCID rates were no better than standard repair.
Weigh the evidence carefully. Only 2 RCTs exist, the rest are level IV case series, and nearly every study was funded by or tied to the manufacturer. One RCT reported an implausible 0% control retear rate.
The signal points toward smaller full-thickness tears benefiting most clinically, and larger tears benefiting most on cost because of faster return to work. Remember the suture-tendon interface is the weak link the implant targets.
Bottom line for the exam and the OR: this is a promising augment with better radiographic healing but unproven functional superiority, and the appropriate indications are not yet defined.
Retear remains the main problem after rotator cuff repair, and the Regeneten bioinductive collagen implant is marketed to improve healing. This systematic review pooled 17 studies covering 1062 tears (966 treated with Regeneten) to assess retear rates, imaging, clinical scores, and cost. It asks whether adding this implant actually improves outcomes over conventional repair.
When you weigh a biological augment for rotator cuff repair, separate two questions: does it heal the tendon, and does the patient feel better? For Regeneten the answer splits. Retear rates dropped in some studies and one RCT, and MRI showed real new tissue by 6 months, but clinical scores and MCID rates were no better than standard repair.
Weigh the evidence carefully. Only 2 RCTs exist, the rest are level IV case series, and nearly every study was funded by or tied to the manufacturer. One RCT reported an implausible 0% control retear rate.
The signal points toward smaller full-thickness tears benefiting most clinically, and larger tears benefiting most on cost because of faster return to work. Remember the suture-tendon interface is the weak link the implant targets.
Bottom line for the exam and the OR: this is a promising augment with better radiographic healing but unproven functional superiority, and the appropriate indications are not yet defined.