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临床试验/NCT01033188
NCT01033188已完成不适用

Single Bundle or Double Bundle Anterior Cruciate Ligament Reconstruction. A Randomized, Controlled Trial.

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年1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
120
试验地点
1
主要终点
KOOS score(QOL)

研究概览

简要总结

There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one of the most common orthopaedic procedures performed, especially among young, active and healthy individuals. However, reports state that there is a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are unable to regain prior function. Additionally, it has been reported that degenerative joint disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the patients in long term follow up studies.

It is well known that the ACL is composed of 2 functional bundles named after their tibial attachments, the anteromedial (AM) and posterolateral (PL) bundles.

It is believed that the current single-graft, single-bundle technique for reconstructing the anterior cruciate ligament does not anatomically reconstruct either one of these bundles.

In the last two years, the double bundle technique has been introduced and a few clinical studies are available, however only a few RCTs.

Further study is very important to determine if double-bundle ACL reconstructions should be performed, if single-bundle reconstructions can be adjusted to better adapt to their biomechanical insufficiency in restoring internal rotation torques and valgus moments, and also in trying to identify which patients might better benefit from single-bundle versus double-bundle ACL reconstructions.

详细描述

The aim of this study:

The primary aim is to compare the two operational techniques: single bundle hamstrings versus double bundle hamstrings ACL reconstruction, using the KOOS (Knee Osteoarthritis Outcome Score) Quality of Life(QoL) subscore as the primary outcome and clinical examinations, functional tests and standing radiographs (Kellgren Lawrence method) as secondary outcome measurements. Those assesments will be measured after 1,2 and 5 years after the operation.

Hypothesis:

There are no difference between the two methods as judged by the KOOS QoL subscore.

Questions to be answered:

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 (Investigator)

入排标准

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

入选标准

  • Clinically verified ACL rupture (history, Lachman test 2+ or more with no endpoint; pos pivot shift and arthroscopically verified) The graft used for AM bundle has a minimum size of 6.0 mm and 5.0 mm for t he PL bundle.

排除标准

  • PCL injury,
  • ACL injury to the contra lateral knee
  • > 1+ medial or lateral-posterolateral ligament instability at operation date
  • Previous ACL reconstruction
  • Meniscal injury leaving < 50% of the meniscus intact
  • Established OA as judged by Kellgren 3-4.

结局指标

主要结局

KOOS score(QOL)

时间窗: 1-5 years

次要结局

  • Standing radiographs (Kellgren Lawrence methode)(3-5 years)

研究者

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

Lars Engebretsen

Professor

Oslo University Hospital

研究点 (1)

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