A RANDOMIZED TRIAL OF REALIGNMENT THERAPY FOR TREATMENT OF MEDIAL KNEE ARTHRITIS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。在负重过程中，内侧间隙吸收膝关节60%-70%的力，部分原因是由于内侧间隙比外侧间隙承受更大的压力，骨关节炎对胫股内侧间隙的影响在男性和女性中都比外侧关节腔大得多。由于这一间隙的介入特别频繁，临床上有时会使用旨在重新调整膝关节以减少内科间隙的跨关节负荷的干预措施，如外翻支撑。尽管多年来人们知道改变膝骨性关节炎患者的负荷可能是一种安全、廉价和有效的治疗方式，但很少有研究评估这些治疗方法，而且这些研究要么规模较小，要么有其他方法学上的局限性。这个为期3年的项目的总体目标是确定在内侧膝关节骨性关节炎患者中提供重排治疗是否缓解了膝关节疼痛并改善了功能。我们将检验这一假设，即与对照治疗相比，使用重排疗法(外翻膝关节支架+运动控制鞋+矫形器)在膝关节内侧骨关节炎中有效。具体目标是：a.对膝关节内侧骨关节炎患者进行为期16周的随机交叉临床试验，以确定在此治疗期间，提供调整治疗是否比使用安慰剂治疗期间疼痛评分更低、功能改善；b.进行一项开放标签跟踪研究，以跟踪治疗的使用和效果。该项目将由第二代膝盖支撑公司共同出资。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The medial compartment absorbs 60-70% of the force across the knee during weight bearing and, in part, because it is subjected to more stress than the lateral compartment, osteoarthritis affects the medial tibiofemoral compartment much more often than the lateral one in both men and women. Since involvement of this compartment is especially frequent, interventions whose goal is to realign the knee so as to reduce transarticular loading on the medical compartment, such as valgus bracing are sometimes used clinically. Despite knowing for many years that altering loads in patients with knee OA may be a safe, inexpensive and an effective modality of treatment, there have been few studies that have evaluated these therapies, and these studies are either small or have other methodologic limitations. The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee OA relieves knee pain and improves function. We will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA. The specific aims are: a. To undertake a 16-week, randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment; b. To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by Generation II, a knee bracing company.