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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
Sponsor: Smith & Nephew, Inc.
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.
Official title: Evaluation Of Clinical and Health Economic Outcomes Following Rotator Cuff Repair Using the REGENETEN◊ Bioinductive Implant: A Prospective, Multi-Center Global Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2020-10-01
Completion Date
2029-12-31
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
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.
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