Post surgical pain management in knee replacement for osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
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
Sponsors
North Cumbria Integrated Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed