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Compression after surgery of the knee

A single-centre, two-arm, controlled, prospective randomized trial comparing standard crepe bandaging with Andoflex TLC Calamine Lite (25-30 mmHg) compression bandaging after knee surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10011099
Enrollment
148
Registered
2021-11-17
Start date
2021-10-06
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee surgery Surgery

Interventions

Standard care (control) arm As soon as the operation is finished and a wound dressing has been applied, the standard bandaging is applied. One layer of soft synthetic bandage, stretching from proximal

Sponsors

North Cumbria Integrated Care NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026