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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotator Cuff Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rotator cuff repair using REGENETEN

Patients undergoing arthroscopic rotator cuff repair using the REGENETEN Bioinductive Implant

Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No