RecruitingNCT06857084

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant

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


Sponsor

Smith & Nephew, Inc.

Enrollment

400 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation for people with rotator cuff injuries. The study is currently recruiting participants at 22 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEArthroscopic 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.


Locations(22)

Melbourne Orthopaedic Group

Windsor, Victoria, Australia

Schoen Klinik Lorsch

Lorsch, Rhine, Germany

Schoen Klinik Dusseldorf

Düsseldorf, Germany

Malteser Waldkrankenhaus Erlangen

Erlangen, Germany

Sporthopaedie Heidelberg

Heidelberg, Germany

St. Anna Hospital

Herne, Germany

Artemed Klinikum München Süd

München, Germany

OrthoMedicum Mittelhessen

Stadtallendorf, Germany

Regional General Hospital F. Miulli

Acquaviva delle Fonti, Apulia, Italy

Ospedale Israelitico

Roma, Italy

Ospedale di Sassuolo

Sassuolo, Italy

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Spire Harpenden Hospital

Harpenden, Hertordshire, United Kingdom

Spire Montefiore

Brighton, Hove, United Kingdom

Burnley General Hospital

Burnley, Lancashire, United Kingdom

Burnley General Teaching Hospital

Burnley, Lancashire, United Kingdom

Manchester University NHS Foundation Trust

Manchester, Lancashire, United Kingdom

Grantham and District Hospital

Grantham, Lincolnshire, United Kingdom

University College London Hospitals

London, London, United Kingdom

Cleveland Clinic London Hospital

London, London, United Kingdom

Sulis Hospital Bath

Bath, Somerset, United Kingdom

West Hertfordshire Hospitals NHS Trust

Hertford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06857084


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