Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Apley's distraction test
研究概览
简要总结
In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. The aim of the study is to assess subjective and objective functional outcome of ACL reconstruction with follow-up at least 3 years. MRI scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. IKDC, KOOS scales will be utilised for subjective evaluation. Clinical tests such as Lachman's, pivot shift, Appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. Additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured .
Preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. All cases available for the study will be assessed with methodology above. Dedicated statistical test will be utilised to evaluate the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 10-17 years at time of surgery
- •ACL full thickness lesion
- •meniscal lesions repaired simultaneously
- •completed research protocol
排除标准
- •age <10 yo and >17 yo.
- •PCL concomitant injury
- •polytrauma
- •other same knee surgeries performed before intervention
结局指标
主要结局
Apley's distraction test
时间窗: up to six months
Assessment of knee rotational stability (positive/negative)
Lachman test
时间窗: up to six months
Assessment of knee stability in sagittal plane (positive/negative)
Pivot shift test
时间窗: up to six months
Assessment of knee rotational stability (positive/negative)
Isokinetic evaluation - torque at 30 deg
时间窗: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of torque at 30 deg (Newton-meter, \[Nm\])
Isokinetic evaluation - angle of peak torque
时间窗: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of angle of peak torque (degrees \[deg\]))
Isokinetic evaluation - work fatigue
时间窗: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of work fatigue (percent \[%\])
MRI evaluation
时间窗: up to 12 months
Assessment of reconstructed ACL morphology and degenerative changes of the knee - cartilage average volume (cubic centimeter) \[cm3\]
Isokinetic evaluation - peak torque
时间窗: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of peak torque (Newton-meter, \[Nm\])
Arthrometer testing
时间窗: up to six months
Assessment of knee stability in sagittal plane with digital arthrometer use (millimeters, \[mm\])
Isokinetic evaluation - time to peak torque
时间窗: up to 12 months
Quadriceps and hamstrings isokinetic tests in either 60 deg/s and 180 deg/s velocities with evaluation of time to peak torque (milliseconds \[ms\])
次要结局
未报告次要终点