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临床试验/NCT02795247
NCT02795247已完成不适用

Three Dimensional Computed Tomography Comparison of the Transtibial, Modified Transtibial and Anteromedial Portal Technique for Recreation of the Anterior Cruciate Ligament Anatomic Footprint

OrthoCarolina Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月26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
30
试验地点
1
主要终点
3D reconstructed CT imaging

研究概览

简要总结

The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
  • •Skeletally mature patients
  • •Patients who are able and willing to receive post-operative CT imaging of the affected knee

排除标准

  • •Previous ACL reconstruction in the studied knee
  • •Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy

研究组 & 干预措施

Accessory Anteromedial Portal Technique

Active Comparator

Reconstruction of the ACL using the accessory anteromedial portal technique

干预措施: Anterior Cruciate Ligament Reconstruction (Procedure)

Transtibial Technique

Active Comparator

Reconstruction of the ACL using the transtibial technique.

干预措施: Anterior Cruciate Ligament Reconstruction (Procedure)

Hybrid Transtibial Technique

Active Comparator

Reconstruction of the ACL using the hybrid transtibial technique

干预措施: Anterior Cruciate Ligament Reconstruction (Procedure)

结局指标

主要结局

3D reconstructed CT imaging

时间窗: 6 weeks Post-Operatively

Used to measure tunnel position.

次要结局

  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation(2 year post-operative)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(2 year post-operative)
  • Knee Laxity(6 month post-operatively)
  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation(6 weeks post-operative)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(6 weeks post-operative)
  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation(6 months post-operative)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(6 months post-operative)
  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation(1 year post-operative)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(1 year post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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