PMCF and Continuous Development

  • Research type

    Research Study

  • Full title

    Post Market Clinical Follow Up and Continuous Development of Upper Limb Prosthetic Devices

  • IRAS ID

    344154

  • Contact name

    Thor Fridriksson

  • Contact email

    thfridriksson@ossur.com

  • Sponsor organisation

    Ossur

  • Duration of Study in the UK

    5 years, 0 months, 0 days

  • Research summary

    The aim of this study is to collect information on the performance of upper limb prosthetic devices, such as prosthetic hands, when used by individuals with limb absence. Professionals involved in prescribing and fitting the devices will also be included. The study is sponsored by Össur which manufactures the prosthetic devices to be tested in the study. The majority of devices being tested are commercially available (UKCA/CE marked) but device modifications may also be evaluated when required and with appropriate justification. The results of the study will influence the design and development of prosthetic devices, leading to improved devices for patients in the future.

  • REC name

    North of Scotland Research Ethics Committee 2

  • REC reference

    24/NS/0066

  • Date of REC Opinion

    1 Jul 2024

  • REC opinion

    Further Information Favourable Opinion