STRYKER Retrospective Foot and Ankle data collection

• Research type

  Research Study

• Full title

  A Retrospective Data Collection study of the Internal Fixation and Reconstruction of Bones in the Foot & Ankle using various devices: Charlotte MUC screw; DARCO heads; CROSS CHECK 3Di; OrthoLoc 3Di

• IRAS ID

  311135

• Contact name

  Andrew Bing

• Contact email

  andrew.bing@nhs.net

• Duration of Study in the UK

  0 years, 4 months, 30 days

• Research summary

  This is a single site, retrospective post-market data collection study designed to collect safety and performance Standard of Care data on patients who have undergone routine lower limb surgery that involved one of the following implant devices as per the indication for use:
  • DARCO™ Headed Cannulated Screw
  • ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
  • ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
  • CHARLOTTETM Multi-Use Compression (MUC) Screw System

  The retrospective data collection will involve reviewing patient's electronic records for data gathered during routine clinical care. No new data will be collected or additional investigations performed; as such, patient consent will not be sought.

  No data will leave the Trust and analysis will be performed by the CI at the Trust. A final report detailing the safety and performance of the implants will be shared with the manufacturer and published appropriately.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  22/SW/0027

• Date of REC Opinion

  2 Mar 2022

• REC opinion

  Favourable Opinion