NCT00925626已完成不适用
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- VAS, KOOS and HSS scales
研究概览
简要总结
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with osteoarthrosis of the knee
- •patients must be in good general health condition
排除标准
- •patients with morbid obesity (BMI >45)
- •patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
结局指标
主要结局
VAS, KOOS and HSS scales
时间窗: at day 1, day 2, day 3, day 4 and day 5 post-operatively
Rehabilitation time; time needed for 90° flexion of the knee joint
时间窗: post-operatively
次要结局
- VAS, HSS, KOOS questionnaires(at 6 weeks, 3 months and 12 months after surgery.)
- Amount and type of analgesic drugs used.(pre-operatively and post-operatively)
研究者
研究点 (2)
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