Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Anterior Cruciate Ligament Reconstruction With or Without Concomitant AnteroLateral Ligament Reconstruction.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 762
- 试验地点
- 2
- 主要终点
- Knee stability
研究概览
简要总结
This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.
详细描述
This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded.
Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •primary ACL injury
排除标准
- •no informed consent to participate in the study
- •age under 18 years or above 65
- •multilligament injury or single plane knee instability (medial, lateral)
- •another musculoskeletal disorders in lower limb
- •lower limb deformity requiring axis correction below 4o or above 12.5o
- •joints inflammatory diseases
- •ASA score > II
结局指标
主要结局
Knee stability
时间窗: 24 months
KT-1000 assesment for knee stability
次要结局
- IKDC (International Knee Documentation Committee) subjective knee evaluation(24 months)
- Functional tests(12 months)
- VAS (Visual analog scale)(24 months)
- KOOS (Knee injury and Osteoarthritis Outcome Score)(24 months)
- Tegner Lysholm Knee Scoring Scale(24 months)
- SF-36 (36-Item Short Form Survey)(24 months)
- KOOS PF (Knee injury and Osteoarthritis Outcome Score Patellofemoral)(24 months)
研究者
Rafał Kamiński
Professor CMKP
Centre of Postgraduate Medical Education