跳至主要内容
临床试验/NCT03626883
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

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

发起方
Rafał Kamiński
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rafał Kamiński

MD, PhD

Centre of Postgraduate Medical Education

研究点 (2)

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