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临床试验/NCT01909596
NCT01909596已完成不适用

Does it Exist a Relationship Between Inclination Angle of Foot Orthoses and Varus Angle of the Knee in the Relief of the Knee Osteoarthritis Symptoms?

Laval University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Knee adduction moment

研究概览

简要总结

The purpose of this is to test lateral foot orthoses with different amount of wedging to find a model that predicts the optimal lateral inclination of foot orthosis based on biomechanical or feelings measures. This study was a cross-sectional study with patients serving as their own control. The investigators recruited 24 knee osteoarthritis. Knee radiography and clinical angles measures was carried out before making orthoses, then motion analysis with an optoelectronic system was performed with each pair of foot orthoses. During motion analysis, five gait trials were carried out in each condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic medial knee osteoarthritis (OA ; Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
  • Knee pain > 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
  • Moderately active
  • Varus knee alignment equal or superior to 2°

排除标准

  • Severe knee OA (K-L grade IV)
  • Rheumatoid arthritis or other inflammatory arthritis
  • Avascular necrosis
  • History of periarticular fracture or septic arthritis
  • Bone metabolic disease
  • Pigmented villonodular synovitis
  • Cartilaginous disease
  • Neuropathic arthropathy
  • Synovial osteochondromatosis
  • Total or partial knee arthroplasty
  • Flexion contracture of ipsi- or contra-lateral knee greater than 15°
  • Hip or ankle joint damage with mobility limitation
  • Obesity (BMI ≥ 40)
  • Intra-articular corticosteroids injection in the affected knee during the two previous months
  • Reduced mobility (Charnley class C)

结局指标

主要结局

Knee adduction moment

时间窗: At time of device receipt

Measure of the knee adduction moment is a non invasive technic to identify change in medial knee loading, major problem in medial knee osteoarthritis.

Knee pain

时间窗: At time of device receipt

A 20-cm visual analog scale (0-100) is used to assess pain.

次要结局

  • Foot orthoses comfort(At time of device receipt)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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