Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial
Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial
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DOI：
10.1016/j.joca.2006.02.004
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发表时间：
2006-08-01
影响因子：
7
通讯作者：
Bierma-Zeinstra, S. M. A.
中科院分区：
文献类型：
--
作者：
Brouwer, R. W.;van Raaij, T. M.;Bierma-Zeinstra, S. M. A.
目的：评估用于减轻内侧或外侧室性骨关节炎（OA）和并发内翻或外翻对准患者负荷的支具的效果。设计：本多中心随机对照试验（2001-2003年进行）研究了在单室膝关节炎保守治疗中，支架减少负荷的累加效应。地点：一所大学医疗中心和一所综合医院的骨科。随访12个月。患者：117例膝关节单室性OA。干预组（n = 60）包括保守治疗加支架治疗，对照组（n = 57）包括单独保守治疗。主要结局指标：疼痛严重程度和膝关节功能评分。次要结局指标：步行距离和生活质量。分析：根据意向-治疗原则，采用多元线性回归模型评估全组患者的结局差异。此外，我们对主要总体结果进行了探索性亚组分析，这些结果按对齐、OA程度、OA来源和年龄分层。结果：虽然干预组在各评估点的主要结局指标均较对照组有所改善，但差异仅达到临界显著性。支架组在3个月、12个月和总体上报告的步行距离均明显更长（P= 0.03、P= 0.04和P= 0.02）。亚组分析显示，内翻组、严重OA患者、继发性OA患者和60岁以下患者疗效较好。支具组25例患者和对照组14例患者改变了最初的治疗方案，大多数（74%）是因为缺乏有益效果。结论：结果表明，用于减轻负荷的支具对单室骨关节炎患者效果不大。然而，许多患者并没有长期坚持这种保守治疗。(C) 2006国际骨关节炎研究学会。Elsevier Ltd.出版。版权所有。
Objective: To evaluate the effect of a brace intended to reduce load in patients with medial or lateral compartmental osteoarthritis (OA) and concurrent varus or valgus alignment, respectively.Design: This multi-centre randomized controlled trial (performed 2001-2003) studies the additive effect of a brace intended to reduce load in conservative treatment of unicompartmental OA of the knee. Setting: Orthopedic department of a university medical centre and of one general hospital. The follow-up was 12 months. Patients: 117 patients with unicompartmental OA of the knee. Intervention group (n = 60) comprising conservative treatment with additional brace treatment and a control group (n = 57) comprising conservative treatment alone. Primary outcome measures: Pain severity and knee function score. Secondary outcome measures: Walking distance and quality of life. Analysis: Multiple linear regression models according to the intention-to-treat-principle were used to assess outcome differences for the entire group of patients. In addition, we performed explorative subgroup analyses on primary overall outcomes stratified for alignment, degree of OA, origin of OA, and age.Results: Although the primary outcome measures were improved in the intervention group in comparison with the controls at each assessment point, the differences reached only borderline significance. The reported walking distances at 3 months, 12 months and overall were significantly longer in the brace group (P= 0.03, P= 0.04 and P 0.02, respectively). Subgroup analysis showed a better effect in the varus group, in patients with severe OA, in patients with secondary OA and in patients younger then 60 years. In total 25 patients in the brace group and 14 in the control group changed their initial treatment, mostly (74%) because of a lack of beneficial effect.Conclusions: The results indicate that a brace intended to reduce load shows small effects in patients with unicompartmental OA. However, many patients do not adhere in the long run to this kind of conservative treatment. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.