Evaluation of different knee cooling devices to control pain after knee replacement surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: 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 inde Xknee. 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 si Xto 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 inde Xknee. As with standard treatment arm, the VPULSE cuff is applied over the routine surgical wound dressing. The cryotherapy effect is achieved by ci CONDITION: Post surgical pain management in knee replacement for osteoarthritis ; Musculoskeletal Diseases PRIMARY OUTCOME: 1. Pain at rest is measured using the visual display scale (VDS) at baseline at pre‐surgery, and 1, 3, 5,12 days and 6 weeks post‐surgery; 2. Pain (walking) is measured using the visual display scale (VDS) at baseline at pre‐surgery, and 1, 3, 5,12 days and 6 weeks post‐surgery; 3. Types of pain are measured using the McGill pain questionnaire at baseline at pre‐surgery, and 1, 3, 5,12 days and 6 weeks post‐surgery; 4. Knee limb range of motion is measured with a goniometer at baseline at pre‐surgery, and 6 weeks post‐surgery; 5. Knee functionality is measured with validated KOOS score at baseline at pre‐surgery, and 6, 12 weeks post‐surgery; 6. Patient satisfaction with the allocated cooling therapy is measured at 5 days post‐surgery SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 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
Epistemonikos ID: 3717f57f6a304e3b579078f6868a1422892aa6ce
First added on: Aug 28, 2024