NCT01150929已完成不适用
Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Radio Stereometric Analysis
研究概览
简要总结
The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.
The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.
排除标准
- •Neurologic disease with impact on gait.
- •Orthopaedic disease ipsilateral hip joint.
- •Patients outside the age limits.
- •No informed consent signed.
- •Patients suffering from dementia.
- •Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
- •Patients who later develop deep venous thrombosis or infection in the operated knee.
结局指标
主要结局
Radio Stereometric Analysis
时间窗: 24 months
Patients are analysed with stereo x-rays to asses implant micromigration.
次要结局
- Gait analysis(12 months)
- DXA(24 months)
研究者
研究点 (2)
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