NCT00120952撤回不适用
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Migration of femoral components evaluated by RSA
研究概览
简要总结
In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.
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
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip
- •Spinal anesthesia
- •Informed written consent
排除标准
- •Neuromuscular disease in the affected leg
- •Vascular disease in the affected leg
- •Fracture sequelae in the affected hip
- •Weight over 100 kg
- •Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
结局指标
主要结局
Migration of femoral components evaluated by RSA
次要结局
- Periprosthetic BMD changes evaluated by DEXA
研究者
研究点 (2)
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