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Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears — IMPACT  

Rotator Cuff Injuries Clinical Trial

Official title:
Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)

Clinical Trial Summary

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Clinical Trial Description

The primary objective of this study is to evaluate the functional recovery of patients with high grade (>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05444465
Study type Interventional
Source Smith & Nephew, Inc.
Contact Judith Horner
Phone +44 (0) 1482673251
Email Judith.Horner@smith-nephew.com
Status Recruiting
Phase N/A
Start date August 30, 2022
Completion date June 30, 2027
View Details
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