ARAVET : Antero-lateral Ligament Reconstruction Versus Modified Lemaire's Lateral Extra-articular Tenodesis in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Graft rupture rate
研究概览
简要总结
Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion.
Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon).
The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated.
Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion.
To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up.
The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman with age between 18 and 50 years old
- •disabling anterior chronic laxity
- •1 criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test
- •Patient who signed the informed consent form.
排除标准
- •any associated procedure (excluding meniscal resection or repair) like osteotomy or meniscus graft
- •pregnant patient
- •Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care
- •Adults under legal protection
结局指标
主要结局
Graft rupture rate
时间窗: At 24 months post-operative
Graft rupture rate (percentage)
次要结局
- International Knee Documentation Committee (IKDC) score(Pre-operatively and at 6, 12 and 24 months post-operatively)
- Complications(Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively)
