Comparison of Functional Outcomes in Patients Using Knee Brace and Without Knee Brace After Anterior Cruciate Ligament Reconstruction Surgery With Autograft Bone Quadricep Tendon Arthroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Lysholm score 3 months post treatment
研究概览
简要总结
This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.
详细描述
This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.
The research will be conducted at the National Central General Hospital dr. Cipto Mangunkusumo, Jakarta Police Hospital and Gatot Soebroto Army Hospital in Jakarta, Indonesia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with age more than equal to 18 years
- •Patients with ACL rupture without other ligament ruptures undergoing ACL reconstruction
- •Patients undergoing ACL reconstruction using Quadricep Tendon Autograft
排除标准
- •Patients with hyperlaxity
- •Patients with previous history of ACL reconstruction
- •Patients with recurrent rupture during the observation period
结局指标
主要结局
Lysholm score 3 months post treatment
时间窗: 3 months
Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes
International Knee Documentation Committee (IKDC) score 6 months post treatment
时间窗: 6 months
Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes
Lysholm score 6 months post treatment
时间窗: 6 months
Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes
Knee injury and Osteoarthritis Outcome (KOOS) score 3 months post treatment
时间窗: 3 months
The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Knee injury and Osteoarthritis Outcome (KOOS) score 6 months post treatment
时间窗: 6 months
The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment
时间窗: 6 months
Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes
International Knee Documentation Committee (IKDC) score 3 months post treatment
时间窗: 3 months
Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes
Rolimeter 3 months post treatment
时间窗: 3 months
Objective examination of knee stability using a rolymeter
Rolimeter 6 months post treatment
时间窗: 6 month
Objective examination of knee stability using a rolymeter
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 3 months post treatment
时间窗: 3 months
Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes
次要结局
未报告次要终点
研究者
Danarto Hari Adhimukti
Principal Investigator
Indonesia University