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

Launched by SMITH & NEPHEW, INC. · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the results of a specific treatment for shoulder injuries called rotator cuff repair, using a special implant called the REGENETEN Bioinductive Implant. The study will gather real-world information from patients across various countries, including the UK, Europe, and Australia. It aims to include up to 400 patients who will undergo this surgery and be followed for up to two years to see how well the treatment works.

To join the study, participants need to be over 18 years old and require surgery for rotator cuff tears, which can be either partial or full thickness. However, individuals with certain mental health or neurological conditions, or who do not meet specific medical guidelines, will not be eligible. Those who participate can expect to receive standard medical care and will be asked to provide information about their recovery and outcomes after the surgery. This trial is currently recruiting patients, and it’s a great opportunity for those needing this type of surgery to contribute to important research.

Gender

ALL

Eligibility 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.