Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dynamic Stability with force platform
研究概览
简要总结
This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction.
One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately.
This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint.
It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.
详细描述
Tunnel position will be recorded and confirmed with postoperative computer tomography.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical activity classified by Tegner scale ≥ 5
- •Absence of other associated ligament injuries in the operated knee
- •No ACL rerupture or previous ACL reconstruction in the same or other knee
- •Absence of untreated lesions of the opposite knee
- •No obvious change in the alignment of the mechanical axis that required surgical correction
- •Athletes of both gender with a minimum age of 18 years and maximum of 45 years
- •Signature of the consent term (IRB)
- •Not be pregnant.
排除标准
- •Request to stop the study by patient at any time
- •Fracture not associated with the surgical procedure
- •Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.
研究组 & 干预措施
AM anatomical ACL reconstruction
Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction
干预措施: Anatomical ACL reconstruction (Procedure)
CENTRAL anatomical ACL reconstruction
Femoral and tibial tunnels performed in the center of ACL footprint
干预措施: Anatomical ACL reconstruction (Procedure)
结局指标
主要结局
Dynamic Stability with force platform
时间窗: 12 months
Evaluation of dynamic stability in stand position and leg movements with force platform
次要结局
- Isokinetic knee strength test - side to side difference(6, 12 months)
- Change from baseline and between groups in Dynamic Stability with force platform(6 months)
- Change from baseline and between groups in International Knee Documentation Committee form (IKDC)(6, 12 e 24 months)
- Change from baseline and between groups in Lysholm knee scoring scale(6, 12, 24 months)
- Change from baseline and between groups in Tegner activity score(6, 12, 24 months)
- Single leg hop test for distance - side to side difference(6, 12 months)
研究者
Arnaldo José Hernandez
Associate Professor, PhD, MSc, MD
University of Sao Paulo