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临床试验/NCT04957797
NCT04957797Unknown不适用

Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
9
试验地点
1
主要终点
simulated pivot-shift test

研究概览

简要总结

The present study was aimed to investigate the kinematics differences between round-tunnel (ROT) and flat-tunnel (FLT) techniques and compare the influence to the anterior root of lateral meniscus (ARLM ) in anterior cruciate ligament (ACL) reconstruction when using hamstring graft.

详细描述

Nine matched pairs of fresh-frozen cadaveric knees were evaluated for the kinematics of intact, ACL-sectioned, and either ROT or FLT reconstructed knees. The graft bundles for FLT technique were separately tensioned. A 6 degrees of freedom robotic system was used to assess knee laxity: (1) 134-N anterior tibial load at 0°, 15°, 30°, 60°, and 90°of knee flexion. (2) 10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30°. (3) 5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90°. (4) 10-Nm varus and valgus torques at 15°, 30°. Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • intact knee with no previous injures

排除标准

  • those with ligamentous injury or a limited range of motion

结局指标

主要结局

simulated pivot-shift test

时间窗: within 1 hour after surgery

10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30° of knee flexion

simulated KT-2000 arthrometer

时间窗: within 1 hour after surgery

134-N anterior tibial load simulates a KT-2000 arthrometer at 0°, 15°, 30°, 60°, and 90°of knee flexion

internal and external rotation

时间窗: within 1 hour after surgery

5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90° of knee flexion

varus and valgus

时间窗: within 1 hour after surgery

10-Nm varus and valgus torques at 15°, 30°of knee flexion

average percentage of ACL tibial footprint coverage

时间窗: within 1 hour after surgery

Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning post-operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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