NCT01448278已完成4 期
Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study
Hospital Ambroise Paré Paris1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain assessment on a Visual Analogical Scale
研究概览
简要总结
The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.
The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Total or partial tear of the Anterior Cruciate Ligament
排除标准
- •Patient refusal
研究组 & 干预措施
All-inside technique
Experimental
干预措施: "All-inside" (Procedure)
Classical technique
Active Comparator
干预措施: Classical technique (Procedure)
结局指标
主要结局
Pain assessment on a Visual Analogical Scale
时间窗: One month after surgery
次要结局
- Pain assessment on a Visual Analogical Scale(First ten days)
- Analgesics consumption(First ten days)
- Functional evaluation with IKDC score(Change from base-line in IKDC objective score at 6 months)
- Discharge of crutches and orthesis(Time frame from surgery)
- Radiographic analysis of tunnels positioning according to Aglietti's criteria(One month after surgery)
研究者
Shahnaz Klouche, MD
Physician Responsible of Clinical Research
Hospital Ambroise Paré Paris
研究点 (1)
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