title: Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study.
abstract: BACKGROUND
  Enhanced recovery programmes in total knee arthroplasty are well established. Post-operative knee swelling is common and impairs early post-operative function. The use of a short-stretch, inelastic compression bandage is hypothesised to reduce knee swelling and improve pain and early function. A study was designed to test feasibility with a view to informing a larger, future trial and to provide preliminary data.
  
  
  METHODS
  This is a randomised controlled feasibility study. Fifty consecutive patients selected for primary total knee arthroplasty will be enrolled in the trial. Patients with a BMI >35, latex allergy or neurological or peripheral vascular disease are excluded. Patients are randomised by distance randomisation to receive a compression bandage for 24 hours after surgery or a standard wool and crepe bandage. The bandages are applied by one of two consultant surgeons who have had training with their application. Knee swelling, range of motion and pain scores will be compared pre-operatively and at day 1, day 2 and at 6 weeks between groups. The Oxford knee score and EQ-5D health status will be compared pre-operatively and at 6 months between groups. Recruitment rates, retention rates, resource allocation, completeness of data collection, and tolerance and complications with the compression bandage are recorded. Descriptive statistics are used to calculate a standard deviation for post-operative knee swelling in the groups and to perform a power calculation incorporating anticipated patient retention rates to inform a future trial. Preliminary data will be analysed using the independent samples t-test for equal distributions and the Mann-Whitney U for unequal distributions with the significance denoted at P <0.05.
  
  
  CONCLUSIONS
  Enhanced recovery programmes have revolutionized the management of total knee arthroplasty. There is a paucity of clinical data regarding the efficacy of compression bandages. Large, randomised controlled trials are uncommon in orthopaedic surgery. The results of this study will provide feasibility and preliminary data prior to the construction of a larger, multicentre study.
  
  
  BACKGROUND
  The study was registered with Current Controlled Trials ( ISRCTN86903140 ) on 30 May 2013.
authors: NIHR academic clinical fellow and orthopaedic registrar, Wansbeck General Hospital, Woodhorn Lane, Northumberland, NE63 9JJ, UK. t.m.brock@doctors.org.uk.
authors: Timothy M
authors: TM
authors: Brock
authors: Consultant Orthopaedic Surgeon, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK. Andrew.Sprowson@warwick.ac.uk.
authors: Andrew P
authors: AP
authors: Sprowson
authors: Consultant orthopaedic surgeon, Wansbeck General Hospital, Woodhorn Lane, Northumberland, NE63 9JJ, UK. Scott.Muller@nhct.nhs.uk.
authors: Scott
authors: S
authors: Muller
authors: Consultant orthopaedic surgeon, Wansbeck General Hospital, Woodhorn Lane, Northumberland, NE63 9JJ, UK. Mike.Reed@nhs.net.
authors: Mike R
authors: MR
authors: Reed
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects*; D002985:Clinical Protocols; D058128:Compression Bandages; D004185:Disability Evaluation; D004487:Edema / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D004739:England; D004867:Equipment Design; D005240:Feasibility Studies; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology / Q000601:surgery*; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome