Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
研究概览
简要总结
This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.
详细描述
This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.
The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years
- •Clinical and MRI confirmed complete ACL tear
- •Ipsilateral hamstring autograft
- •Concomitant meniscus injury requiring either meniscus repair or partial menisectomy
- •Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)
- •Regular scheduled follow up with adherence to prescribed rehab protocol
排除标准
- •Non consent
- •Paediatric patient; age less than 18 years
- •Partial or incomplete ACL tear
- •Revision ACL surgery
- •Hamstring allograft
- •Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner)
- •Past history of knee surgery
- •Contra-lateral ACL injury or other ligament injury
- •Chondral injury Grade 3,4 (International Cartilage Repair Society)
- •Intra-articular fracture (past or current)
- •Radiologically evident osteoarthritis changes
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
时间窗: Baseline, 1 year and 2 years post op
Patient reported outcome
次要结局
- KOOS Pain change from baseline(Baseline, 1 year and 2 years post op)
- International Knee Documentation Committee (IKDC) Grade change from baseline(Baseline, 1 year and 2 years post op)
- Tegner-Lysholm Score change from baseline(Baseline, 1 year and 2 years post op)
- KOOS Symptoms change from baseline(Baseline, 1 year and 2 years post op)
- KOOS Function in daily living (KOOS ADL) change from baseline(Baseline, 1 year and 2 years post op)
- KOOS Knee-related Quality of Life (KOOS QOL) change from baseline(Baseline, 1 year and 2 years post op)