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临床试验/NCT00076453
NCT00076453已完成不适用

Clinical Effects of Altered Biomechanics in Knee Osteoarthritis

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Pain reduction

研究概览

简要总结

Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.

详细描述

Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disability, as well as enormous economic burden on the patient; unfortunately, treatment provides relief but not a cure. The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief, even with recent advances in pain relievers. Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA.

Although OA is complex and not completely understood, disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading. Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration; one such device is a lateral wedge orthotic shoe insert. When worn during weight-bearing activity, these inserts have been shown to reduce loading of the medial compartment and may provide pain relief. This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA. The study will also assess improvements in loading biomechanics of the knee.

This is a 3-year study. Patients will be randomly assigned to one of two groups; the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts. There will be 10 study visits during the course of the study. Patients will undergo X-rays and bone mineral density testing (DEXA) and 3 blood collections during the course of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able and willing to give informed consent and to comply with the study protocol and follow-up instructions
  • Symptomatic and radiographic OA of the knee
  • Knee pain upon walking
  • Predominant medial compartment OA

排除标准

  • Knee flexion contracture of greater than 15 degrees or inability to walk without assistance
  • Predominant lateral compartment OA of either knee
  • Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
  • Clinically evident OA of the ankle or hip
  • Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
  • Substantial obesity, defined as having body mass index (BMI) greater than 35
  • Anticipation of surgery involving any joint of either lower extremity in the next 3 years
  • Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
  • Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
  • Chronic infection in any joint of the lower extremities
  • History of fracture of either lower extremity within 6 months of study entry
  • History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
  • History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
  • Pregnancy
  • Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol

研究组 & 干预措施

1

Experimental

Participants will wear lateral wedge orthotic inserts.

干预措施: Lateral wedge orthotic shoe inserts (Device)

2

Active Comparator

Participants will wear standard orthotic inserts.

干预措施: Standard orthotic shoe inserts (Device)

结局指标

主要结局

Pain reduction

时间窗: Years 2 and 3

次要结局

  • Reduction in loading of the medial knee(Years 2 and 3)

研究者

申办方类型
Other

研究点 (1)

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