NCT04450342

REGENETEN™ Bioinductive Implant System in Full-thickness Tears

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
DEVICE	Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation	The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
PROCEDURE	Arthroscopic rotator cuff repair	The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
DEVICE	Arthroscopic rotator cuff repair for revision surgery	The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.

Timeline

• Start date: 2020-12-07
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2020-06-29
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

30 sites across 8 countries: United States, Australia, Canada, France, Hong Kong, Singapore, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study