跳至主要内容
临床试验/NCT00300300
NCT00300300终止4 期

Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.

Queen's University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2009年9月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
125
试验地点
2
主要终点
The main outcome under investigation is knee laxity as reflected by graft tension.

研究概览

简要总结

ACL reconstruction in the Division of Orthopaedic surgery at Queen's is currently being performed arthroscopically assisted. The resultant function of the reconstructed ligament is greatly influenced by the placement of the transosseous tunnels, which are tunnels in the bones through which the grafts pass. Presently the placement of the tunnels is being judged from arthroscopically identified anatomical landmarks within the joint. The result is incidence rates of misplaced tunnels as high as 40%. Computer assisted tunnel placement would aid in the correction and reproducibility of anatomic tunnel placement. The objective of this study is to conduct a prospective, randomized trial comparing clinical and radiographic outcomes in subjects who receive either a patella or hamstring tendon graft to reconstruct a chronic tear of the anterior cruciate ligament. All subjects will be further randomized into a computer-assisted or a conventional arthroscopic surgical group to allow investigators to compare the precision and accuracy of tunnel placement between these surgical approaches. The main question under investigation is: does the increased accuracy of computer-assisted surgery make a clinical difference to the laxity of the reconstructed knee, and is the laxity further influenced by the type of tendon graft received?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

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

  • Diagnosis of a chronic unilateral rupture of the anterior cruciate ligament
  • Aged 18-40

排除标准

  • Acute injury of the ACL (interval between the injury and operation is < 30 days).
  • Other ligament tears and/or operation on the operative knee (with the exception of a previous meniscectomy).
  • Injury of the contralateral knee.
  • Degenerative changes of the articular cartilage (grade III or IV changes according to the Outerbrige classification system)
  • Complaints of patellofemoral symptoms
  • Patient is pregnant
  • Inability to complete 2-year follow-up

研究组 & 干预措施

1

No Intervention

applying a patellar graft using conventional surgical technique.

2

No Intervention

applying a hamstring graft using conventional surgical technique.

3

Experimental

applying a patellar graft using a computer-assisted surgy technique.

干预措施: Computer-assisted surgery (Procedure)

4

Experimental

hamstring graft CAOS

干预措施: Computer-assisted surgery (Procedure)

结局指标

主要结局

The main outcome under investigation is knee laxity as reflected by graft tension.

时间窗: 2 years

次要结局

  • Other outcomes of interest include graft isometry, position and size as well as knee pain, stiffness, function, and range of motion.(2 years)

研究者

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

Dr. David Bardana

Principal Investigator

Queen's University

研究点 (2)

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