“Comparison of outcome of anterior cruciate ligament reconstruction using hamstring autograft with and without augmentation, A prospective randomized control trial.â€
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Tegner activity scale
研究概览
简要总结
Methodology-
We will first clinically assess the patient withchronic ACL tear for signs (subjective tests) and symptoms of ACL injury. Allthe demographic information of the patient like age, sex, occupation, side ofaffected limb, mode of injury, injury operation interval involvement in sportsactivities will be collected. Patient will have to get preanesthetic clearance.Patient will be evaluated for Visual analogue score for pain, Lysholmfunctional knee score, Tegner activity scale, KT1000 Laxity measurement andsubjective tests for knee laxity and results will be recorded. On the background of diagnosis and symptoms,patient fulfilling the above mentioned criteria will be allocated in two groupafter proper randomization and treated accordingly. Post operatively patient will be followed upat 2, 4 and 6 months. In follow-up of the patient will be again evaluated forVisual analogue score for pain, Lysholm functional knee score, Tegner activityscale KT1000 Laxity measurement and subjective testsfor knee laxity and results will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 16.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA: a)Isolated complete ACL tear b)ACL deficient Patients having symptom of instability or giving way of the involved knee.
- •c)Patient age 16-40 year d)No radiological arthritic changes in affected knee.
- •e)Patient willing to participate in study.
排除标准
- •EXCLUSION CRITERIA- a)ACL injury associated with other collateral ligament and posterior cruciate ligament injury.
- •b)Asymptomatic ACL deficient patients c)Age less than 16 year or more than 40 year.
- •d)Radiological arthritic changes in affected knee.
- •e)Patient refused to participate in study f)Any prior surgery in ipsilateral knee.
结局指标
主要结局
•Tegner activity scale
时间窗: SIX MONTHS AFTER THE SURGERY
•KT 1000 arthrometer laxity measurements
时间窗: SIX MONTHS AFTER THE SURGERY
•Lysholm functional knee score
时间窗: SIX MONTHS AFTER THE SURGERY
•Subjective examination {Lachmen test, Anterior drawer test, Pivot shift test}
时间窗: SIX MONTHS AFTER THE SURGERY
•Pain ( visual analogue scale)
时间窗: SIX MONTHS AFTER THE SURGERY
次要结局
- PROTECTIVE EFFECT OF AUGMENTATION(Post operatively patient will be followed up at 2, 4 and 6 months)