NCT00346788已完成4 期
The Subvastus Approach in Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus 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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You are willing to take part in the study, including signing this form after carefully reading it.
- •You are available for follow-up for a minimum of 24 months (2 years).
- •You have no medical conditions that prevent you from having surgery.
- •This is the primary (first) knee replacement for this knee
- •You are fluent in English and are able to understand your responsibilities in this study.
排除标准
- •Active, local or systemic infection
- •Fibromyalgia or other chronic pain syndrome
- •Inability to follow the study requirements
- •Had this knee replaced before
- •Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
- •Body Mass Index (BMI) > 35, as you would not be eligible for the MIS approach.
结局指标
主要结局
Length of hospital stay
时间窗: Post Operative
Range of motion at discharge and six weeks post-operatively
时间窗: Discharge and six weeks post operative
次要结局
- Wound complications(post operative until wound healed)
- Post-operative narcotic use(24 months post operative)
- Post-operative blood loss(Post operative)
- The ability to straight-leg raise at two and twenty-four hours post-operatively(2 and 24 hours post operative)
- Knee Society Clinical Rating Scale(pre-op, 6 months, 12 months, and 24 months post operative)
- SF-12(pre-op, 6 months, 12 months, and 24 months post operative)
- WOMAC.(pre-op, 6 months, 12 months, and 24 months post operative)
研究者
研究点 (2)
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