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临床试验/NCT02993679
NCT02993679已完成不适用

Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study

Hospital Znojmo0 个研究点目标入组 60 人开始时间: 2014年7月1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
60
主要终点
Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.

研究概览

简要总结

The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

详细描述

Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

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
17 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The isolated ACL lesion
  • The absence of the previous surgery on the knee joint
  • The body mass index (BMI) less than 30.

排除标准

  • Associated injuries of the tissue around the knee joint

结局指标

主要结局

Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.

时间窗: 24 months after the operation

Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.

次要结局

未报告次要终点

研究者

发起方
Hospital Znojmo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Komzak Martin, M.D.

General Hospital Znojmo

Hospital Znojmo

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