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临床试验/NCT04940169
NCT04940169已完成不适用

Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts

SB Istanbul Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
VAS

研究概览

简要总结

Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.

详细描述

Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed primary ACL rupture willing to involve study
  • lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries

排除标准

  • more than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength

结局指标

主要结局

VAS

时间窗: Change from baseline score at one year.

Simple patient reported questionnaire

KOOS

时间窗: Change from Baseline score at one year.

Simple patient reported questionnaire

lysholm

时间窗: Change from Baseline score at one year.

Simple patient reported questionnaire

IKDC

时间窗: Change from baseline score at one year.

Simple patient reported questionnaire

STRENGTH TEST

时间窗: Change from baseline score at one year.

Simple patient reported questionnaire

subjective instability test

时间窗: Change from baseline score at one year.

instability measure with help of examinations

thigh circumference

时间窗: Change from baseline score at one year.

circumference measure

one leg hop test

时间窗: Change from baseline score at one year.

ask to participant hop on operated leg

次要结局

未报告次要终点

研究者

发起方
SB Istanbul Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Neset Tang

attendant

SB Istanbul Education and Research Hospital

研究点 (2)

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