Anterior Cruciate Ligament Reconstruction: Comparison of Patellar With Hamstring Tendon Using a Computer-assisted Versus a Conventional Surgical Technique.
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
- 否
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
applying a patellar graft using conventional surgical technique.
2
applying a hamstring graft using conventional surgical technique.
3
applying a patellar graft using a computer-assisted surgy technique.
干预措施: Computer-assisted surgery (Procedure)
4
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
Dr. David Bardana
Principal Investigator
Queen's University
