NCT01022099已完成不适用
Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- rotational component position
研究概览
简要总结
Evaluation of the component position and kinematics after navigated and conventional Total Knee Arthroplasty.
详细描述
- Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA.
A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge. 2. clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or secondary osteoarthritis of the knee
- •indication to TKA
- •a mechanical axis between 20° varus and 5° valgus
- •signed informed consent
排除标准
- •previous hemi- or total arthroplasty
- •severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
研究组 & 干预措施
navigated TKA
Active Comparator
干预措施: Implantation of a Total Knee Arthroplasty (Procedure)
conventional TKA
Other
干预措施: Implantation of a Total Knee Arthroplasty (Procedure)
结局指标
主要结局
rotational component position
时间窗: postoperatively
次要结局
- leg axis(postoperatively)
- kinematics(postoperatively)
- clinical outcome(18 to 24 month postoperatively)
研究者
研究点 (1)
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