Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction |
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Authors: | Jeannette Hofmeijer G Johan Amelink Ale Algra Jan van Gijn Malcolm R Macleod L Jaap Kappelle H Bart van der Worp |
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Institution: | 1. University of Keele, Keele University Medical School, Thornburrow Drive, Hartshill, Stoke-on-Trent, ST4 7QB, Staffordshire, UK 2. University Hospital of North Staffordshire NHS Trust, Newcastle Road, ST4 7QB, Stoke-on-Trent, UK 3. Newcastle-under-Lyme Primary Care NHS Trust, Civic Offices, Merrial Street, ST5 2AZ, Newcastle-under-Lyme, UK 4. Dept. of Mathematics & Statistics, University of Limerick, Limerick, Ireland
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Abstract: | Background Thirty thousand knee replacements are performed annually in the UK. There is uncertainty as to the best surgical approach to the knee joint for knee arthroplasty. We planned a randomised controlled trial to compare a standard medial parapatellar arthrotomy with sub-vastus arthrotomy for patients undergoing primary total knee arthroplasty in terms of short and long term knee function. Methods Patients undergoing primary total knee arthroplasty at the local NHS Trust are to be recruited into the study. Patients are to be randomised into either the subvastus or medial parapatellar approache to knee arthroplasty. The primary outcome measures will be the American Knee Society and WOMAC Scores. The secondary outcome measures will be patient based measures of EuroQol and SF-36. All outcomes will be measured pre-operatively, 1, 6, 12 and 52 weeks post-operatively. We will also review pain intensity using a pain and analgesia diary. Ease of surgical exposure and complications will also be analysed. Discussion Evidence is lacking concerning the best surgical approach to the knee joint for patients undergoing primary total knee replacement. This pragmatic randomised trial tests the hypothesis that the sub-vastus approach is significantly superior to the standard medial parapatellar approach in terms of short and long term knee function. |
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