NCT05962580已完成不适用
of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- failure rate
研究概览
简要总结
Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients
详细描述
It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High demand patients (manual workers, athletes,...etc.).
- •Normal average body mass index ( 18.5 - 24.9 ).
- •Age <40 years old.
- •Patients will be diagnosed as ACL tear by the following:
- •History of knee traumatic event.
- •Clinical examination ( positive Lachman test and pivot shift test).
- •Radiological evidence of ACL tear by MRI.
- •patient with high pivot shift test.
排除标准
- •Generalized ligamentous laxity.
- •Other intra or extra articular knee injuries.
- •Previous ACL surgery on the affected knee.
- •Bilateral ACL injuries.
- •Significant Articular surface injury.
- •Medical comorbidities
- •Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
- •Neuromuscular disorders
- •Knee arthritic changes.
结局指标
主要结局
failure rate
时间窗: one year follow up
retear of ACL graft confirmed by clinical examination and MRI
次要结局
- antero-posterior instability measure(at 3,6,9 and 12 months)
- International knee documentation committee score (IKDC)(at 3,6,9,12 months)
- Lysholm score(at 3,6,9,12 months)
- side to side KT 1000 lachmeter difference(one year follow up)
研究者
研究点 (2)
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