WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY

• Research type

  Research Study

• Full title

  WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY

• IRAS ID

  270988

• Contact name

  Andrew Bing

• Contact email

  Andrew.bing@nhs.net

• Sponsor organisation

  Wright Medical

• Clinicaltrials.gov Identifier

  NCT04118894

• Duration of Study in the UK

  12 years, 0 months, 1 days

• Research summary

  Wright Medical is conducting the Foot and Ankle Observational Study to meet the new clinical data requirements for the EU MDR. The purpose of this post-market clinical observational study is to demonstrate the safety/performance of the Wright Medical product after implantation over standard follow-up period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays). Additionally, PROMs and safety may be followed yearly to sufficiently assess the safety of the product over the clinical lifetime as needed based on the current risk analysis for the product. The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).
  The study will demonstrate the safety and performance of the Wright Medical product by:
  • Comparing the improvements in patient-reported pain and social interaction for QOL from pre-op through post-operatively, assessed by the EQ-5D-5L.
  • Comparing the improvement in patient-reported function scores from pre-op through post-operatively, assessed by the FAAM
  • Identifying/reporting the safety of the implant in terms of complications and adverse events.
  • Conducting a surgeon survey including radiographic assessment of fusion and consolidation time
  • Conducting patient surveys to assess current implant status (to include complications)

  Subjects to be included in the study must meet all of the following criteria:
  • Willing/able to consent to participate (written, informed consent);
  • Willing/ able to attend/complete the requested follow-up visits;
  • Considered for treatment with one or more approved or cleared Wright Medical products included in this study

  Subjects will be excluded from the study if they meet any of the following criteria:
  • Subjects determined, by the investigator, to be an inappropriate candidate for the procedure indicated;
  • Unable to consent to participate (written, informed consent);
  • Unable to attend/complete the requested follow-up visits

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  19/WM/0380

• Date of REC Opinion

  31 Dec 2019

• REC opinion

  Favourable Opinion