Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Lysholm score
研究概览
简要总结
The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.
详细描述
Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).
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
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-35 years old.
- •Patients will be diagnosed as ACL tear by the following:
- •I. History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI.
排除标准
- •Other intra or extra articular knee injuries.
- •Previous ACL surgery on the affected knee.
- •Bilateral ACL injuries.
- •Significant Articular surface injury.
- •Medical comorbidities
- •Patients with malalignment (genu varum. Genu valgum and Genu recurvatum)
- •Neuromuscular disorders
研究组 & 干预措施
anterior cruciate ligament reconstruction with internal suture augmentation technique
This group will be operated by using all-inside ACLR technique with internal suture augmentation technique
干预措施: all- inside anterior cruciate ligament reconstruction (Procedure)
anterior cruciate ligament reconstruction without internal suture augmentation technique
This group will be operated by using all-inside ACLR technique without internal suture augmentation technique
干预措施: all- inside anterior cruciate ligament reconstruction (Procedure)
结局指标
主要结局
Lysholm score
时间窗: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
Lachmeter examination
时间窗: 9 months
objective measurement of knee laxity
International Knee Documentation score (IKDC) score
时间窗: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
次要结局
- knee ROM(9 months)
研究者
Ahmed abdelaziz Ramadan
orthopedic surgery registrar
Ain Shams University