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

orth Cumbria Integrated Care NHS Foundation Trust0 个研究点目标入组 122 人开始时间: 2021年11月17日最近更新: 2024年4月22日

适应症

试验速览

•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

•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

发起方

orth Cumbria Integrated Care NHS Foundation Trust