Outcomes after TKA using two cryocompression devices
Research type
Research Study
Full title
Outcomes after total knee arthroplasty when using either a gravity-assisted or electronic continuous cold-flow cryocompression device during the acute post-operative period.
IRAS ID
345621
Contact name
John Barter
Contact email
Sponsor organisation
Physiolab Technologies Ltd
ISRCTN Number
ISRCTN51498119
Duration of Study in the UK
0 years, 9 months, 26 days
Research summary
The application of cold and pressure following knee surgery is known to result in superior clinical outcomes compared to when none is used. Cryocompression therapy aims to reduce swelling, inflammation, and pain by reducing blood flow and nerve sensitivity in the area. There are several different technologies available that provide cryocompression therapy with varying levels of control over treatment variables. Gravity-assisted devices and electronic continuous cold-flow devices both work by taking ice-water from a central reservoir to a cuff wrapped around the desired therapy area. The cuff of gravity-assisted devices is filled with cold water and then left in-situ until it re-warms, at which point the cuff can be drained and re-filled with more cold water. Electronic devices continuously pump user-determined temperature-controlled water through the cuff from the central reservoir, while the cuff applies a pre-selected level of compression. The aim of this study is to compare the clinical outcomes of patients following total knee replacement surgery when using either a gravity-assisted or electronic cryocompression device as part of their acute post-operative rehabilitation. This will allow clinicians and patients in future to choose the most effective modality for cryocompression therapy to improve and optimise post-operative outcomes. Adult patients undergoing unilateral total knee replacement surgery at a single private hospital in the UK will be eligible for recruitment to this study. Participants will be randomised to receive either a gravity-assisted or electronic device to be used in hospital following their operation and for the first 2 post-operative weeks while at home.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0078
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Favourable Opinion