Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ASL Lecce
- 入组人数
- 100
- 主要终点
- graft rerupture rate
研究概览
简要总结
This study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction.
Combined ACL and ALL reconstruction is increasingly used to improve rotational knee stability and reduce the risk of graft failure after ACL injury. However, the optimal knee position for fixing the ALL graft during surgery remains unclear. In this study, patients were treated with ALL fixation performed either in full knee extension (0 degrees) or at 30 degrees of knee flexion.
Clinical outcomes, knee stability, patient-reported function, and graft failure rates were compared between the two groups at a minimum follow-up of two years. Outcomes were assessed using validated questionnaires, clinical examinations, and objective measurements of knee stability.
The study aims to determine whether the knee flexion angle at the time of ALL fixation influences postoperative function, stability, or complication rates, and to provide clinical evidence to guide surgical technique in combined ACL and ALL reconstruction.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a unilateral anterior cruciate ligament (ACL) rupture confirmed by clinical examination and magnetic resonance imaging (MRI)
- •Persistent knee instability despite conservative treatment
- •Ability to understand the study procedures and provide written informed consent
- •Willingness to comply with the postoperative rehabilitation protocol and follow-up schedule
排除标准
- •Previous ACL reconstruction or revision surgery on the affected knee
- •Bilateral ACL injuries
- •Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1
- •Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)
- •History of neurological, vestibular, or visual disorders affecting balance or gait
- •Inflammatory joint disease or systemic musculoskeletal disorders
- •Incomplete baseline clinical data
- •Inability to complete patient-reported outcome questionnaires or attend follow-up visits
研究组 & 干预措施
ALL Fixation at 0 Degrees of Knee Flexion
Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee in full extension (0 degrees) during surgery.
干预措施: anterolateral ligament reconstruction (Procedure)
ALL Fixation at 30 Degrees of Knee Flexion
Participants undergoing combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction in which the ALL graft is fixed with the knee flexed at 30 degrees during surgery.
干预措施: anterolateral ligament reconstruction (Procedure)
结局指标
主要结局
graft rerupture rate
时间窗: 24 months
Graft rerupture is defined as a failure of the reconstructed anterior cruciate ligament (ACL), diagnosed by clinical evidence of knee instability and confirmed by imaging findings consistent with graft discontinuity or revision surgery.
次要结局
- anterior knee laxity(24 months)
- pivot shift test(24 months)
- kinesiophobia(24 months)
- subjective knee function(24 months)