Arcos Clinical Outcomes Study, Revision 2

  • Research type

    Research Study

  • Full title

    Arcos Modular Femoral Revision System Clinical Outcomes Study

  • IRAS ID

    268526

  • Contact name

    Vijay Killampalli

  • Contact email

    vijay.killampalli@nhs.net

  • Sponsor organisation

    Zimmer GmbH

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    The primary aim of this retrospective and prospective Clinical Outcomes Study, is to report the clinical and radiographic results from revision hip arthroplasty, using the commercially available cementless Arcos Modular Femoral Revision System.

    This data collection will occur at a single UK centre, and will review a consecutive series of patients who have previously received the implant by the Chief Investigator, Mr. Killampalli and have a minimum of 12 months FUP.

    Subjects who agree to participate in the Clinical Outcomes Study and provide written consent, will be required to attend a single prospective post-operative follow-up visit.
    At this visit they will undergo a clinical evaluation of their Arcos revision stem, which will involve having an X –ray of their hip and completing a series of patient questionnaires.
    Retrospective data collection will be performed to collect patients’ demographic information and pre-operative conditions and operative procedures. Any previous post-operative follow-up data prior to study commencement will also be collected retrospectively.
    The aim is to collect high quality data, which will allow for publication in a peer-reviewed journal.

  • REC name

    West Midlands - South Birmingham Research Ethics Committee

  • REC reference

    19/WM/0222

  • Date of REC Opinion

    1 Aug 2019

  • REC opinion

    Unfavourable Opinion