SAFE-TKR Study
Research type
Research Study
Full title
Safety and Feasibility Evaluation of Tourniquets for Total Knee Replacement Study
IRAS ID
193449
Contact name
Peter D H Wall
Contact email
ISRCTN Number
ISRCTN20873088
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
The majority of surgeons perform Total Knee Replacement surgery with the aid of a tourniquet. The tourniquet interrupts the blood supply and drainage from the leg and helps to create a bloodless field. A tourniquet may however increase a patients’ risk of developing a blood clot. At the end of surgery the tourniquet is deflated and blood clots that may have accumulated in the leg are immediately free to flow (embolise) within the blood stream. In some cases blood clots and debris can return to the heart where they are then free to travel to the brain. \nThe potentially increased risk of clots and debris in the brain associated with using a tourniquet has never been examined with any definitive randomised controlled trials (RCTs) and it is unclear if such a RCT would even be feasible. A feasibility study is therefore planned and will comprise three parts:\ni.\tPilot randomised controlled trial. Patients due for TKR surgery will invited to take part in a pilot trial and randomised to surgery with or without a tourniquet with a view to recruiting 50 patients. All patients will undergo a Magnetic Resonance (MR) imaging scan of their brain before and after surgery to look for evidence of clots and debris in the brain. Other potentially important outcomes including knee pain and function within 12 months will also be collected.\nii.\tIntegrated qualitative research study. An interview study of around 30 patients and around 20 surgeons will capture the views and opinions of both groups regarding the acceptability of the pilot trial. \niii.\tRetrospective multi-centre cohort study. A study of an existing database of TKR surgery in England and Wales (National Joint Registry-NJR) will be undertaken. The data will be mapped to other existing databases of deaths and hospital reported blood clots.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0455
Date of REC Opinion
27 Jan 2016
REC opinion
Further Information Favourable Opinion