High tibial osteotomy Surgery
Conditions
Interventions
A total of 68 patients will be recruited and allocated to either standard bandaging (34 patients) or 3M Coban compression bandaging (also 34 patients)
follow-up of patients will be up to 12 weeks post-surgery. Apart from clinical outcomes data, such as incidence of infection and deep vein thrombosis/pulmonary embolism, plus readmission to hospital,
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient who is listed for unilateral high tibial osteotomy using a fixed plate device at one of participating NHS Trusts 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. Ankle brachial index measured within 12 weeks 5. 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 high tibial osteotomy 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 anticoagulant medication 7. Any skin or other condition that contraindicates the use of compression bandaging, including diabetic foot ulcer and peripheral neuropathy 8. Patients who are participating in another interventional research study involving an investigational product related to the osteotomy 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. Ankle brachial index < 0.8 or lack of foot pulses, measured within 12 weeks of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of operation-site related pain experienced at day 12 post-operation and average pain scores in the control and Coban arm, measured using the 10 cm visual descriptor scale (VDS) for pain; Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-operative patient-reported outcome measures are recorded using Visual Display Scale pain and short form McGill pain questionnaire at 5, 12 days, and 6, 12 weeks post-surgery 2. Quality of night rest measured by Richards-Campbell Sleep Questionnaire (two consecutive nights per timepoint) prior to surgery as baseline, and 12 days and 6 weeks post-surgery 3. Degree of swelling of affected limb recorded by measurement of thigh, suprapatellar and calf girth prior to surgery as control, and 12 days, 3 weeks post-surgery 4. Knee function and quality of life measured using the Knee and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), quality of life measured with EQ-5D-5L prior to surgery as baseline, and 12 weeks post-surgery 5. Descriptive safety overview obtained by recording readmissions to theatre and/or hospital, infection of wound site , and diagnoses of pulmonary embolism or deep vein thrombosis at 30 days and 12 weeks post-surgery | — |
Countries
United Kingdom
Outcome results
None listed