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REGENETEN™ Bioinductive Implant System in Full-thickness Tears

NCT04450342 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2025-05-23

Study results available
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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.

Conditions

  • Rotator Cuff Injuries

Interventions

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Peach, MBBS MD FRCS (Tr&Orth) · Manchester University NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Hong Kong
  • Singapore
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450342 on ClinicalTrials.gov