ROBOT; Reported Outcomes for Bandaging after Osteotomy Trial
Research type
Research Study
Full title
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.
IRAS ID
236602
Contact name
Matt Dawson
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
ISRCTN Number
ISRCTN15376709
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Medial osteoarthritis – wearing of the inside of the knee joint – can be treated with medial wedge high tibial osteotomy (HTO for short). This procedure involves cutting the tibial bone and introducing an opening wedge to change the angle of the knee joint and thereby shift the patient’s weight from the medial to the lateral side (outside) of the knee. This then negates the need for a partial or total knee replacement. As with other major knee operations, post-surgery a lot of swelling can develop in and around the site of operation. This is painful, may increase the risk of surgical wound infection and can limit a patient’s progress with post-operative mobilisation. Therefore, research is already ongoing in the field of knee replacement surgery to determine if different type of bandaging of the affected leg post-surgery may improve patient and clinical outcomes. A new method is now available which involves bandaging that compresses the leg. This may reduce pain and swelling because fluid cannot build up as easily. This present study aims to assess if compression bandaging is better than standard non-compression bandaging in terms of keeping a patient comfortable by reducing pain, swelling and enabling early mobilisation. 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, patient-reported outcomes will be recorded too. These include pain experienced, degree of swelling of the affected leg, and knee joint functionality. The main objective of the study is whether 3M Coban bandaging is significantly better than standard bandaging at day 12 post-surgery when measured on a visual display pain scale.
REC name
Wales REC 7
REC reference
18/WA/0027
Date of REC Opinion
29 Jan 2018
REC opinion
Favourable Opinion