WELBOW

  • Research type

    Research Study

  • Full title

    WELBOW – WRIGHT™ Elbow Outcomes Clinical Study

  • IRAS ID

    266531

  • Contact name

    A.C. Watts

  • Contact email

    Adam.C.Watts@wwl.nhs.uk

  • Sponsor organisation

    Wright Medical Group N.V.

  • Clinicaltrials.gov Identifier

    NCT04173377

  • Duration of Study in the UK

    12 years, 0 months, 1 days

  • Research summary

    The WELBOW study is an International, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF) study.

    The objective of this multi-center study is to collect preoperative, intraoperative, short, intermediate, mid-term and long-term data on the related clinical complications and functional outcomes of market-approved Wright Medical Elbow products to demonstrate safety and performance of these implants in a real-world setting.

  • REC name

    North West - Greater Manchester East Research Ethics Committee

  • REC reference

    20/NW/0444

  • Date of REC Opinion

    20 Jan 2021

  • REC opinion

    Further Information Favourable Opinion