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临床试验/NCT02555917
NCT02555917Unknown不适用

Tibia and Femoral Tunnel Location Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

The Catholic University of Korea0 个研究点目标入组 40 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location

研究概览

简要总结

Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. For leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure.

Recently many studies reconstructed at anatomical lesion instead of isometric point. And some cadaver studies reported that tibial insertion of anterior cruciate ligament has "C" shape. There are two methods for anterior cruciate ligament reconstruction. One is preserving remnant and the other is removing remnant.

This study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.

详细描述

The study design is a double-blind randomized controlled trial. Randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Visual Analog Score, lachman test, anterior laxity, Lysholm knee score, international knee documentation committee score. Femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using Bernard quadrant method after surgery.

The present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 19 years old
  • patients for ACL reconstruction having medicare insurance

排除标准

  • infection
  • previous surgery experience
  • progressive osteoarthritis

结局指标

主要结局

Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location

时间窗: 1 week after surgery

The locations of the tunnels will be quantified and presented as the percentage distance from the deepest subchondral contour and the intercondylar notch roof to the center of the tunnel by use of the Bernard quadrant method.

次要结局

  • Visual Analog Score for pain(6weeks, 3months, 6months and 1years after surgery)
  • Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation(6weeks, 3months, 6months and 1years after surgery)
  • Lysholm knee score for functional outcome(6weeks, 3months, 6months and 1years after surgery)
  • International Knee Documentation Committee Score for functional outcome(6weeks, 3months, 6months and 1years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong In

Professor

The Catholic University of Korea

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