A multi-centre, two-arm, controlled, prospective randomized trial of 3M Coban dual-layer compression bandaging versus non-compression bandaging after high tibial osteotomy surgery

Cumbria Partnership NHS Foundation Trust0 个研究点目标入组 49 人开始时间: 2018年3月21日最近更新: 2021年8月24日

适应症

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33531268/ (added 10/08/2021)

•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

•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

发起方

Cumbria Partnership NHS Foundation Trust