ALASKA trial
Research type
Research Study
Full title
ALASKA trial, A single-centre, two-arm, controlled, prospective randomized trial comparing AIRCAST® KNEE CRYO/CUFF™ passive compressive cryotherapy with VPULSE® active compressive cryotherapy after knee arthroplasty surgery
IRAS ID
322564
Contact name
Cristian Nita
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
Clinicaltrials.gov Identifier
RD-KAPPA-2022, RD-KAPPA-2022
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Medial osteoarthritis – wearing of the inside of the knee joint – can be treated with knee replacement procedures, where either part or the whole of the knee joint is replaced. For all major knee operations, post-surgery the site of operation can be painful. Increased pain may limit a patient’s progress with post-operative mobilisation. Therefore, research is already ongoing in the field of knee surgery to determine if different type of bandaging and cooling of the affected leg post-surgery may improve patient and clinical outcomes. A relatively new method is now available which involves a combination of active compression and cooling, rather than passive compression and cooling. This may reduce pain. This present study aims to assess if active compression and cooling is better than standard passive compression and cooling in terms of keeping a patient comfortable by reducing pain and possibly improving other clinical outcomes too. A total of 88 patients will be recruited and allocated to either standard care AIRCAST® KNEE CRYO/CUFF™ (passive compression & cooling; 44 patients) and new intervention VPULSE® (active compression & cooling; 44 patients); follow-up of patients will be up to 12 weeks post-surgery. Apart from clinical outcomes such as the degree and type of pain experienced by patients, safety data such as incidence of infection and deep vein thrombosis/pulmonary embolism, plus readmission to hospital will be recorded too. The main objective of the study is whether VPULSE® is significantly better than standard AIRCAST® KNEE CRYO/CUFF™ (either worn for up to 48 hours post-surgery or up to hospital discharge) at day 5 post-surgery when measured on a visual display pain scale.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0186
Date of REC Opinion
8 Mar 2023
REC opinion
Favourable Opinion