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临床试验/NCT02000258
NCT02000258已完成不适用

Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2003年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages

研究概览

简要总结

Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.

Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •primary ACL reconstruction, closed growth plates

排除标准

  • •ligament injury to the opposite knee

研究组 & 干预措施

Double-bundle ACL reconstruction

Other

Double-bundle ACL reconstruction

干预措施: Double-bundle ACL reconstruction (Procedure)

Magnetic resonance imaging (MRI)

Other

MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery.

干预措施: Magnetic resonance imaging (MRI) (Device)

结局指标

主要结局

The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages

时间窗: 2 years after surgery

The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view.

The visibility of the ACL grafts measured from the MRI

时间窗: 2 years after surgery

Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen.

次要结局

  • Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form(2 years after surgery)
  • KT-1000 measurement (mm) of the knees of 61 patients(2 years after surgery)
  • International Knee Documentation Committee (IKDC) functional score(2 years after surgery)
  • Lysholm knee evaluation score(2 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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