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

Last updated: February 26, 2025
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation

Clinical Study ID

NCT06857084
REGENETEN Global Registry
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Subject requires Arthroscopic rotator cuff repair (ARCR);

  • Patients aged over 18 years old at the time of consent and providing baseline databefore undergoing rotator cuff repair surgery (either partial or full thicknesstears) will be eligible for this prospective registry.

Exclusion

Exclusion Criteria:

  • Subject who, in the opinion of the Investigator, has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in theregistry including mental illness, intellectual disability, and drug or alcoholabuse.

  • Subjects who do not meet the indication or are contraindicated according to specificSmith+Nephew REGENETEN System's Instructions for Use (IFUs);

  • Subject that meets the definition of a Vulnerable Subject per ISO14155:2020 Section 3.44.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Arthroscopic rotator cuff repair with REGENETEN Bioinductive Implant augmentation
Phase:
Study Start date:
October 01, 2020
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Melbourne Orthopaedic Group

    Windsor, Victoria 3181
    Australia

    Site Not Available

  • Clinique Saint Christophe

    Soissons, Aisne 02200
    France

    Site Not Available

  • Schoen Klinik Lorsch

    Lorsch, Rhine 64653
    Germany

    Site Not Available

  • Schoen Klinik Dusseldorf

    Düsseldorf, 40549
    Germany

    Site Not Available

  • Malteser Waldkrankenhaus Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Sporthopaedie Heidelberg

    Heidelberg, 69121
    Germany

    Site Not Available

  • St. Anna Hospital

    Herne, 44649
    Germany

    Site Not Available

  • OrthoMedicum Mittelhessen

    Stadtallendorf, 35260
    Germany

    Site Not Available

  • Regional General Hospital F. Miulli

    Acquaviva delle Fonti, Apulia 70021
    Italy

    Site Not Available

  • Spire Harpenden Hospital

    Harpenden, Hertordshire AL5 4BP
    United Kingdom

    Active - Recruiting

  • Spire Montefiore

    Brighton, Hove BN3 1RD
    United Kingdom

    Active - Recruiting

  • Burnley General Hospital

    Burnley, Lancashire BB10 2PQ
    United Kingdom

    Active - Recruiting

  • Burnley General Teaching Hospital

    Burnley, Lancashire BB10 2PQ
    United Kingdom

    Active - Recruiting

  • Manchester University NHS Foundation Trust

    Manchester, Lancashire M23 9LT
    United Kingdom

    Active - Recruiting

  • Grantham and District Hospital

    Grantham, Lincolnshire NG31 8DG
    United Kingdom

    Active - Recruiting

  • Sulis Hospital Bath

    Bath, Somerset BA2 8SF
    United Kingdom

    Active - Recruiting

  • Cleveland Clinic London Hospital

    London, SW1X 7HY
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

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