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临床试验/NCT05923710
NCT05923710已完成不适用

Comparison of Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis for Proximal ACL Tears: A Prospective Study

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年2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
38
试验地点
2
主要终点
Comparison of functional outcomes between two groups of patients who underwent ACL repair surgery with or without lateral extraarticular tenodesis (LET) with International Knee Documentation Committee (IKDC).

研究概览

简要总结

The investigators aimed to compare the clinical results of primary repairs and Lateral Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL tears.

详细描述

The investigators aimed to compare the clinical results of primary repairs and Lateral Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL tears.The aim of this study was to determine the potential for improvement with the primary repair of acute ACL tears with the proximal tear, which may be an important advance for improvements in proprioception and preservation of natural kinematics.

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
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients who underwent surgery within the first 3 weeks after injury
  • between the ages of 21-40 years,
  • attended regular follow-up visits,
  • Sherman type 1 proximal ACL tear with relatively preserved synovial sheath
  • Sufficient tissue length for re-stretching.

排除标准

  • torn ACL in the mid and distal region,
  • torn synovial sheath,
  • inability to undergo intrasubstance suturing,
  • poor tissue quality with retraction,
  • multiple ligament injuries and accompanying intra-knee pathologies (meniscal damage, chondral damage),
  • previous knee surgery,
  • rheumatologic diseases

结局指标

主要结局

Comparison of functional outcomes between two groups of patients who underwent ACL repair surgery with or without lateral extraarticular tenodesis (LET) with International Knee Documentation Committee (IKDC).

时间窗: 24 months

The outcomes were evaluated using various measures, including the International Knee Documentation Committee (IKDC). The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

Comparison of functional outcomes between two groups of patients who underwent ACL repair surgery with or without lateral extraarticular tenodesis (LET) with Tegner-Lysholm scoring system.

时间窗: 24 months

The outcomes were evaluated using various measures, including theTegner-Lysholm scoring system. The Tegner Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bulent KARSLIOGLU

Orthopedics and Traumatology specialist,Chief assistant

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (2)

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