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
Post surgical pain management in knee replacement for osteoarthritis
Control (standard care) arm - AIRCAST® KNEE CRYO/CUFF™ Once the operation is finished, a wound dressing is applied and a standard bandage is applied. It consists of one layer of soft synthetic bandage, stretching from proximal tibia to distal femur covered by a further layer of crepe bandage prior to or after tourniquet deflation, with 50% overlap of each layer. Once transferred to the ward for recovery, this standard bandage will be removed and AIRCAST® KNEE CRYO/CUFF™ cryotherapy is applied to the patient’s index knee. This is a sleeve containing iced water and it will be utilised for up to 48 hours post-operation or until patient discharge, whichever of the two is sooner. The CRYO/CUFF™ is designed to combine the therapeutic benefits of controlled cold compression to minimise hemarthrosis and swelling and reduce pain. The cuff is anatomically designed to completely fit the knee providing maximum coverage of the whole joint and allowing the whole surface area to have the continual cooling benefit of cryotherapy. The cuff is attached to the Gravity Aircast Cryo/Cuff Cooler and will hold water and ice needed for six to eight hours of cryotherapy. Intervention arm - VPULSE® Once the operation is finished, a wound dressing is applied and a standard bandage is applied. It consists of one layer of soft synthetic bandage, stretching from proximal tibia to distal femur covered by a further layer of crepe bandage prior to or after tourniquet deflation, with 50% overlap of each layer. Once transferred to the ward for recovery, this standard bandage will be removed and VPULSE compression cryotherapy is applied to the patient’s index knee. As with standard treatment arm, the VPULSE cuff is applied over the routine surgical wound dressing. The cryotherapy effect is achieved by circulating cold water using a pump rather than gravity-driven cryotherapy with the current Aircast Cryo/Cuff set up that is standard care. The VPULSE also achieves compression by intermittent dynamic c
1. Patient who is listed for knee arthroplasty (replacement) surgery, either partial or total knee replacement (unilateral). 2. Clinical indication, in the opinion of the treating surgeon, that compression & cooling therapy may be of benefit to the patient 3. Adult patients aged > 18 years 4. Mental capacity to give written informed consent
1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 3. Revision of previous knee replacement or osteotomy on the index leg. 4. Limited life expectancy, i.e. undergoing palliative care 5. Any condition that is associated with excessive bleeding, coagulation abnormalities or any other significant haematological condition (e.g. Factor V Leiden, haemophilia). 6. Cardiovascular or vascular condition that in the opinion of the treating surgeon contraindicates the use of compression bandaging, including moderate to severe peripheral arterial disease, venous leg ulcer, high dose anti-coagulant medication 7. Any skin or other condition that contraindicates the use of compression and cooling therapy. 8. Patients who are participating in another interventional research study involving an investigational product related to the knee procedure and its aftercare. 9. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives. 10. Patient has practical or mobility issues which will prevent them from removing the device themselves