Evaluation of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: a Prospective, Multi-Center Global Registry (RePaRe)

Smith & Nephew

Status

Enrolling

Conditions

Rotator Cuff Injuries

Treatments

Device: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT06857084

REGENETEN Global Registry

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.