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

Recruitingn/aAges 18 Years - anyAllSmith & Nephew, Inc.
NCT06857084 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
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Where

22 sites
Melbourne Orthopaedic Group
Windsor, Australia
Schoen Klinik Lorsch
Lorsch, 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

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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