REGENETEN™ Bioinductive Implant System in Full-thickness Tears — REGENETEN  

Rotator Cuff Injuries Clinical Trial

Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR Augmented With REGENETEN™ Bioinductive Implant System in Full-thickness Tears (Large or Massive) Repair Versus ARCR Alone

Status Terminated

Clinical Trial Summary

The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.

Clinical Trial Description

This study is a prospective, multi-center, randomized, controlled clinical study in the treatment of full thickness tears of the rotator cuff (large or massive ≥3 cm in AP or ML according to Cofield classification). The subjects meeting the inclusion/exclusion criteria specified in the protocol will receive either ARCR augmented with REGENETEN or ARCR alone. Subjects enrolled into the revision repair subject group will receive ARCR augmented with REGENETEN. The clinical follow-up evaluation will be performed preoperatively (Baseline), 2 weeks, 6 weeks, 3, 6, 12, and 24 months after surgery, respectively using subjective outcome measures, objective measures of movement and an MRI scan to assess the integrity of the repair and assess the re-tear rate. Health economic data will also be collected. ;

Related Conditions & MeSH terms

• Rotator Cuff Injuries

• NCT number: NCT04450342
• Study type: Interventional
• Source: Smith & Nephew, Inc.
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2020
• Completion date: October 31, 2023