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

NCT05444465 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Injuries

Interventions

DEVICE

Isolated Bioinductive Repair

Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant

PROCEDURE

Completion and Repair

Standard surgical repair using the 'Completion and Repair' technique.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Laura Mills · Smith & Nephew, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2026-08-15
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Spain
  • 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 NCT05444465 on ClinicalTrials.gov