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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry

NCT06857084 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-03-04

No results posted yet for this study

Summary

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation.

Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.

Conditions

  • Rotator Cuff Injuries

Interventions

DEVICE

Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

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.

Sponsors & Collaborators

  • Smith & Nephew Asia Pacific Pte

    collaborator UNKNOWN

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Reid · Smith & Nephew, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2025-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Australia
  • France
  • Germany
  • Italy
  • 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 NCT06857084 on ClinicalTrials.gov