NCT03626883Unknown不适用
Single Versus Double Hamstring Harvest for Anterior Cruciate Ligament Reconstruction. Clinical, Laboratory, Radiographic and Patient-reported Outcomes
Rafał Kamiński2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
研究概览
简要总结
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective and objective outcomes of primary anterior cruciate ligament reconstruction.
详细描述
The aim of the study is to examine the influence of number of the harvested hamstring tendons on subjective (patient-reported outcome measures) and objective (instrument-tested and imaging studies) outcomes of primary anterior cruciate ligament reconstruction.
The study will recruit 60 patients per each of two arms.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic anterior knee instability with MRI-confirmed anterior cruciate ligament tear
排除标准
- •revision anterior cruciate ligament surgery
- •other lower limb injuries
结局指标
主要结局
Knee stability (KT1000 assessment), pivot shift at 2,4 and 5yrs time-points
时间窗: up to 5yrs
次要结局
- Change from baseline Lysholm Knee Questionnaire at 104 weeks(up to 5yrs)
- Need for arthrocentesis, revision surgery, additional procedures up to 104 weeks(up to 5yrs)
- Change from baseline tunnel volume at 104 weeks(104-weeks postop)
- Change from baseline tunnel diameter at 104 weeks(104-weeks postop)
- Change from baseline International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at 104 weeks(up to 5yrs)
- Change from baseline Knee injury and Osteoarthritis Outcome Score at up to 5yrs(up to 5yrs)
- Change from baseline Visual Analog Scale for Pain at 104 weeks(up to 5yrs)
研究者
Rafał Kamiński
MD, PhD
Centre of Postgraduate Medical Education
研究点 (2)
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