Medical and Economical Evaluation of Computer-assisted Reconstruction of the ACL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- IKDC SCORE AT ONE YEAR
研究概览
简要总结
A poor outcome in anterior cruciate ligament (ACL) reconstruction is often related to tunnel position. The researchers believe that improving the accuracy of tunnel position will lead to an improved outcome in ACL surgery. The researchers' purpose is to perform a controlled study on a series of 500 patients in two groups: group I (250 cases) using conventional instrumentation and group II (250 cases) using navigation (Surgetics ACL Julliard protocol).
详细描述
This study compares the percentage of patients in 2 groups (full success) at 1 year of follow up. The results were evaluated on clinical outcome based on the IKDC (International Knee Documented Committee, subjective evaluation) form between one group using conventional instrumentation and another group using navigation.
Secondary Aims:
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To compare in 2 groups:
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Gain of IKDC score at one year (based on pre-operative IKDC score)
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Evolution of IKDC subjective (pre-operative, at 12 months)
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To compare performances at one year (% class A or B) in terms of initial instability measured with laximetry score
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Study of the learning curve
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Evaluate: lasting quality, complication rate, extra-operative time
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Evaluate frequency of thrombovenous complications
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Evaluate delay to return to sport
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First knee surgery
- •Patients more than 18 years old
排除标准
- •Knee surgery already done
- •Patients unable to understand informed consent sheet
结局指标
主要结局
IKDC SCORE AT ONE YEAR
时间窗: ONE YEAR
次要结局
- COMPARISON IKDC SCORE BENEFIT AT ONE YEAR(one year)
- functionnal regaining between two groups at one year(one year)
- evaluate the surgeons' learning in the groups of patients with computer assisted(time of surgery, one year)
- evaluate hospitals' parameters in two groups(time of surgery, time of hospitalization)
- evaluate frequency of complication after surgery (infectious, thrombosis, scar)(6 months, one year)