Compression after surgery of the knee

Not Applicable

Completed

• Conditions: Knee surgery; Surgery

• Registration Number: ISRCTN10011099
• Lead Sponsor: orth Cumbria Integrated Care NHS Foundation Trust

Brief Summary

2024 Results article in https://doi.org/10.1016/j.ijotn.2024.101100 (added 09/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-17
• Study Completion: 2023-10-31
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Patient who is listed for:
1.1. Knee arthroplasty (replacement) surgery, either partial or total knee replacement (single or double)
1.2. Unilateral high tibial osteotomy (HTO) or distal femoral osteotomy (DFO) or a double osteotomy (HTO and DFO) at one of participating NHS Trusts
1.3, In case of double procedure patients, one leg will be classed as the index leg and all outcomes measures will focus on said leg
2. Clinical indication, in the opinion of the treating surgeon, that dual-layer compression bandaging may be of benefit to the patient
3. Adult patients aged >18 years
4. Mental capacity to give written informed consent

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 bandaging, including diabetic foot ulcer or peripheral neuropathy
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain (at rest) measured using the visual analogue score (VAS) at baseline, 3 days, 5 days, 12 days and 6 weeks

Secondary Outcome Measures

Name	Time	Method
1. Pain (whilst walking) measured using the visual analogue score (VAS) at baseline, 3 days, 5 days, 12 days and 6 weeks<br>2. McGill pain profile measured using the visual analogue score (VAS) at baseline, 3 days, 5 days, 12 days and 6 weeks<br>3. Knee/limb range of motion measured using a goniometer at baseline and 6 weeks<br>4. Knee-specific pain profile measured using the KOOS score survey at baseline, 6 weeks and 12 weeks<br>5. Patient satisfaction with the bandaging measured using a non-validated survey at 12 days