Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Patient Reported Function and Pain
研究概览
简要总结
This study is looking at the efficacy of a sloped insole in patients with knee osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain, decreased use of over the counter analgesics, and a clinically important improvement in the Womac pain and stiffness scale.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients 30 years or older with medial compartment knee Osteoarthritis (unilateral) and Grade 4 Kellgren-Lawrence39 radiographic changes presenting for treatment of knee pain.
- •Range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees of extension.
- •Subtalar and forefoot motion permitting foot/ankle eversion with weight bearing.
- •Sufficient shoe toe box height to allow space for the insole and therefore comfort and compliance.
- •Passive laxity of medial capsule and collateral ligament by knee extension test.
排除标准
- •All other forms of knee arthritis other than OA.
- •Knee Instability- medial pseudo-opening of greater than grade 1 or detectable Anterior-posterior instability.
- •Less than Grade 4 Kellgren-Lawrence radiographic changes in the medial compartment of the knee
- •Grade 2 or greater Kellgren-Lawrence radiographic39 involvement of the patellofemoral or lateral compartment.
- •Inadequate knee range of motion
- •Balance problems requiring the use of a walker or wheel chair - ambulation with aid
- •Diabetics with peripheral neuropathy
- •Knee surgery within the past year
- •Intraarticular steroid injection or visco supplementation within 6 months
- •Stiff subtalar or forefoot joints - clinical test
- •Inadequate shoe toe box depth to accommodate the test or control inserts
- •Charcot joint
- •Fixed contracture of the medial capsule and/or collateral ligament- clinical test
研究组 & 干预措施
Wedge Insert
Patients will receive a wedge insert
干预措施: Wedge Insert (Other)
Flat insert
Patients will receive a flat insert
干预措施: Flat Insert (Other)
结局指标
主要结局
Patient Reported Function and Pain
时间窗: 12 months
Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.
次要结局
- Kellgren and Lawrence Classification of Osteoarthritis of Knee(6 months)