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Evaluating outcomes after rotator cuff repair with a special implant

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

Observational Smith & Nephew, Inc. · NCT06857084

This study is testing how well a special implant helps people recover after rotator cuff surgery by tracking their progress for up to two years.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorSmith & Nephew, Inc. Industry-sponsored
Locations19 sites (Windsor, Victoria and 18 other locations)
Trial IDNCT06857084 on ClinicalTrials.gov

What this trial studies

This observational registry collects real-world data from patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant System. Conducted across up to 50 centers in the UK, Europe, and Australia, the study aims to evaluate patient outcomes following surgery. Up to 400 patients will be enrolled, and their progress will be monitored for up to two years post-surgery to assess the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who require arthroscopic rotator cuff repair for either partial or full thickness tears.

Not a fit: Patients with emotional or neurological conditions that affect their ability to participate, or those who do not meet the specific indications for the REGENETEN implant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the REGENETEN implant in improving recovery outcomes for rotator cuff repair patients.

How similar studies have performed: While this approach is based on existing techniques, the specific use of the REGENETEN implant in a multicenter registry is relatively novel and aims to gather comprehensive post-market data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subject requires Arthroscopic rotator cuff repair (ARCR);
* Patients aged over 18 years old at the time of consent and providing baseline data before undergoing rotator cuff repair surgery (either partial or full thickness tears) will be eligible for this prospective registry.

Exclusion Criteria:

* Subject who, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the registry including mental illness, intellectual disability, and drug or alcohol abuse.
* Subjects who do not meet the indication or are contraindicated according to specific Smith+Nephew REGENETEN System's Instructions for Use (IFUs);
* Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

Where this trial is running

Windsor, Victoria and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rotator Cuff InjuriesRotator Cuff RepairRotator Cuff TearFull Thickness TearPartial Thickness TearMassive TearREGENETEN Bioinductive Implant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.