Reported Outcomes for Bandaging after Osteotomy Trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: 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. CONDITION: Specialty: Surgery, Primary sub‐specialty: Orthopaedic Surgery; UKCRC code/ Disease: Musculoskeletal/ Other joint disorders ; Surgery PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: 357406ea3279b68d11df76e97757026ab94215b3
First added on: Aug 24, 2024