ACTRN12609000514202已完成未知
In patients with osteoarthritis of the knee, do cementless total knee replacement components, comparing radiographic micromotion at 6 months and 2 years, provide adequate long-term fixation at the implant-bone interface.
Stryker Australia0 个研究点目标入组 20 人开始时间: 2009年6月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Symptomatic osteoarthritis of the knee requiring intervention.
- •2. Between the ages of 21 and 80 years inclusive.
- •3. Ability to give informed consent.
排除标准
- •1. Significant co-morbidity affecting ability to ambulate
- •2. Flexion contracture greater than 15 degrees
- •3. Extension lag greater than 10 degrees
- •4. Tibial subluxation greater than 10mm on standing radiograph
- •5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
- •6. Lateral or medial collateral ligament instability (>10 degrees varus/valgus)
- •7. Leg length discrepancy greater than 10mm
- •8. Active or prior infection
- •9. Morbid obesity (Body Mass Index, BMI > 40)
- •10. Medical condition precluding major surgery
- •11. Severe osteoporosis or osteopenia
- •12 Neuromuscular impairment
研究者
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