Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study

Trials, Mar 2015

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/design 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. Discussion 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. Trial registration The study was registered with Current Controlled Trials (ISRCTN86903140) on 30 May 2013.

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Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study

Brock et al. Trials Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study Timothy M Brock 2 Andrew P Sprowson 1 Scott Muller 0 Mike R Reed 0 0 Consultant orthopaedic surgeon, Wansbeck General Hospital , Woodhorn Lane, Northumberland NE63 9JJ , UK 1 Consultant Orthopaedic Surgeon, Warwick Medical School, University of Warwick , Coventry CV4 7AL , UK 2 NIHR academic clinical fellow and orthopaedic registrar, Wansbeck General Hospital , Woodhorn Lane, Northumberland NE63 9JJ , UK 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/design: 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. Discussion: 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. Knee replacement; Arthroplasty; Compression bandage; Enhanced recovery; Fast track - Background Total knee replacement is a common and highly successful operation in the management of osteoarthritis. The evolution of enhanced recovery programmes over the last 15 years has reduced hospital stay and morbidity, without increasing readmission rates [1,2]. Post-operative knee swelling is a common problem following total knee replacement. This is largely due to intra-articular bleeding and inflammation of periarticular tissues [3]. Knee swelling results in decreased functional performance as a result of quadriceps weakness [4] and as a result of arthrogenic reflex inhibition due to pain [5]. The resulting decrease in functional performance can delay rehabilitation and affect length of stay and patient-reported outcomes [6,7]. Excessive knee swelling is also associated with increased rates of dehiscence and infection in surgical wounds [8]. Various techniques have been utilised to reduce intra-articular bleeding, including modification of surgical technique [9], tourniquets [10], medication [11] and rehabilitation protocols [12]. Post-operative methods include the use of a cold compress [13], cryotherapy [14], elastic bandaging [15] and compression bandages [16,17]. However, there is a paucity of clinical data regarding the use of compression bandages with heterogeneous methodology. Andersen et al. utilised a compression bandage consisting of a double layer of soft padding and an outer elastic adhesive dressing compared with standard bandage in a randomised controlled trial of 48 patients [16]. The bandage was combined with local anaesthetic infiltration. The intervention group had significantly reduced pain at 8 hours compared to a control group. There was no difference in length of stay. As this was an acute pain study, range of motion, swelling and quality of life were not assessed. A randomised controlled trial of 60 patients undergoing unicondylar knee arthroplasty found no difference in swelling and post-operative pain in patients who received a modified Robert-Jones type bandage compared to a standard wool and crepe bandage when assessed at 24 h and 48 h post-operatively [18]. Conversely, a (...truncated)


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Timothy M Brock, Andrew P Sprowson, Scott Muller, Mike R Reed. Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study, Trials, 2015, pp. 87, 16, DOI: 10.1186/s13063-015-0618-0