Tibial Tunnel Placement for ACL Reconstruction: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
研究概览
简要总结
Although extensive research has been carried out on Anterior Cruciate Ligament (ACL) femoral tunnel placement, very little attention has been given to the tibial tunnel. Researchers have suggested that the tibial tunnel be placed in the center of the ACL footprint, which they described as being approximately 43% of the way (anterior-to-posterior) across the proximal tibia at its widest extent. However, others have suggested that a more anterior placement may yield improved biomechanical and clinical results. The center of the ACL footprint and the posterior aspect of the anterior horn of the lateral meniscus does not yield tibial tunnel placement a consistent percentage of the way across the tibial plateau; therefore, guidelines should be based on intraoperative fluoroscopic measurements. However, the question remaining is what percentage of the anterior-to-posterior distance across the tibia is the ideal location for the tibial tunnel in ACL reconstruction. This study will help answer that question.
Patients with a diagnosed rupture of the ACL who are scheduled for surgical reconstruction will be considered for enrollment. Eligible patients will be allocated to one of two groups based on the location of the tibial tunnel (anterior vs. posterior) during the surgical procedure. In addition to a baseline (pre-operative) evaluation, participants will return for follow-up visits at 6, 12, and 24 months post-surgery. Follow up will be completed at 24 months.
The primary objective of this study is to collect subjective and objective measures of knee-related function in patients with an anterior vs. posterior placed tibial tunnel through 24 months postoperative care.
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 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at time of randomization: 16 - 50 years (skeletally mature)
- •Primary, uncomplicated ACL reconstruction
- •Autograft (STG or BPTB)
排除标准
- •Multiple ligament knee injury (full thickness)
- •Revision ACL reconstruction
- •ACL reconstruction with allograft
- •Meniscectomy > 75%
- •Treatable articular cartilage lesions
- •Diagnosis of tibiofemoral or patellofemoral osteoarthritis (Kellgren Lawrence grade > II)
- •Valgus alignment on long-leg cassette (weight bearing line outside of joint center)
- •Prior surgery in the ankles, knees, or hips
- •Clinical evidence of hip disease
- •Patellofemoral joint instability
- •Significant patellar or tibiofemoral mal-alignment
- •BMI > 35
- •Type 1 Diabetes Mellitus
- •Known connective tissue disorder (e.g. Ehlers-Danlos)
- •Peripheral neuropathy
- •Neurovascular/ circulatory disorder
- •Any form of inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout, lupus, etc.)
- •Significant co-morbid conditions as determined by the investigator (e.g. malignancy, renal, hepatic disease, etc.)
- •Known or suspected psychological disorder
结局指标
主要结局
International Knee Documentation Committee (IKDC) Subjective Knee Joint Evaluation
时间窗: 24 months
Subjective knee-specific function
次要结局
- Knee Injury Outcome and Osteoarthritis Score (KOOS)(24 months)
- Visual Analog Scale (VAS)(24 months)
- Quadriceps Strength(24 months)
- Gait Analysis(24 months)
- Knee Arthrometer (KT-1000)(24 months)
- Marx Activity Rating Scale(24 months)