Lateral Extraarticular Tenodesis vs Anterolateral Ligament Reconstruction with Anterior Cruciate Ligament Reconstruction in High Risk Patients: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the clinical outcomes and functional outcome scores (Tegner-Lysholm Score) in the postoperative period vs preoperative period between the two groups
研究概览
简要总结
Patients who undergo Anterior cruciate ligament reconstruction have often been found to have residual Anterolateral rotatory instability. This is more common in patients who have high risk factors for graft failure (details in inclusion criteria mentioned above). Hence, these patients benefit from an extra articular procedure in addition to Anterior cruciate ligament reconstruction to reduce chance of graft failure and to improve clinical and functional outcomes. Both Lateral extra-articular tenodesis and Anterolateral ligament reconstruction have been advocated as the additional procedures.
In this thesis, we aspire to compare the clinical and functional outcomes of extra-articular procedures performed to minimize residual Anterolateral rotatory instability following Anterior cruciate ligament reconstruction. We will be comparing the outcomes of Lateral extra-articular tenodesis and Anterolateral ligament reconstruction in high risk patients.
The hypothesis for the proposed study is that “Anterior cruciate ligament reconstruction + Anterolateral ligament reconstruction leads to better clinical and functional outcomes compared to Anterior cruciate ligament reconstruction + Lateral extra-articular tenodesisâ€.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients.
排除标准
- •Posterolateral corner injury
- •Lateral compartment Osteoarthritis
- •Patients with prior fractures or surgeries around the knee
- •Skeletal Immaturity.
结局指标
主要结局
To compare the clinical outcomes and functional outcome scores (Tegner-Lysholm Score) in the postoperative period vs preoperative period between the two groups
时间窗: Baseline, 3 months, 6 months and final follow up at 9 months
次要结局
- 1. To compare functional outcomes in both groups using other outcome measures like KOOS score, and IKDC score at 3 and 6 months in high risk patients.(2. To correlate whether risk factors like Segond’s fracture, increased posterior tibial slope, Lateral femoral notch sign, and femoral contusion increase the risk of failure of ACLR and necessitate an extra-articular procedure.)
研究者
Nirvin Paul
AIIMS Rishikesh