Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Vascularity of Graft Tendon
研究概览
简要总结
- Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.
- Subjects: anterior cruciate ligament (ACL) injury 66 patients
- Double bundle transportal technique with flexible reamer: 33
- Single bundle outside in technique with remnant preservation: 33
详细描述
Anterior cruciate ligament (ACL) injury patients : Total 66
- Double bundle transportal technique with flexible reamer: 33
- Advantage: more normal ACL reconstruction than single bundle technique
- Disadvantage: to make the two bone tunnel must remove all the residual tissue.
- Single bundle outside in technique with remnant preservation: 33
- Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery.
- Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lachman test grade II,III and Pivot shift test grade II,III in physical examination
- •ACL rupture in MRI
- •within 6 months after trauma
排除标准
- •osteoarthritis (OA) change in X-ray
- •History of other ligament injury or ACL reconstruction in uninjured knee.
- •operation history of either ipsilateral or contralateral knee(fracture, etc)
结局指标
主要结局
Vascularity of Graft Tendon
时间窗: 1yr after surgery
For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.
次要结局
- Arthroscopy Grading(1yr after surgery)
- Graft Maturity (SNQ)(1 yr after surgery)
- Clinical Knee Scoring(2 yr after surgery)
- Instability(2 yr after surgery)