BOX Ankle Study
Research type
Research Study
Full title
Outcomes of Bologna-Oxford (BOX) Total Ankle Replacement (TAR) – A Single Centre Prospective Observational Cohort Study
IRAS ID
200497
Contact name
Malik Siddique
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
200497, IRAS project reference number
Duration of Study in the UK
5 years, 0 months, 30 days
Research summary
Total ankle replacement helps to improve pain and ankle movement in patients with ankle arthritis. Current prosthetic designs use a three part uncemented ankle joint which has shown encouraging results. The BOX total ankle system is a third generation TAR design which has been designed to provide physiological stability and to achieve accurate positioning of the prosthesis to support the ligaments around the ankle. This implant was starting to be used in the UK since 2008 and so far, over 300 BOX ankle systems have been implanted last year. The aim of our study is to collect comprehensive information on how well this ankle system performs for a total ankle replacement. This will be done by taking X-rays to look at the implant, asking questions about ankle pain and physical activity, measuring the quality of bone, ankle examination and after the surgery and measuring walking patterns and physical activity before and after the operation.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0228
Date of REC Opinion
26 Aug 2016
REC opinion
Further Information Favourable Opinion