Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparing the mean hip rotation between the groups
研究概览
简要总结
The study is designed to evaluate the use of electromagnetic tracking in transversal plane femoral derotation osteotomies. The goal is to raise the precision of the surgical procedure in order to improve the outcome in short- and long term. All patients are examined with an instrumented 3D gait analysis pre- and one year postoperatively. The electromagnetic tracking system is evaluated against a base line CT or MRI scan serving as reference standard pre- and postoperatively.
详细描述
Internal rotation gait is a common deformity in children, especially in those with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral derotation osteotomies have proven to be effective both in short term and long term evaluation. Nonetheless there is still a relevant number of patients that suffer from over- or under-correction and recurrence over time. The reasons are diverse and include false measurement of the derotation in OR.
The study now evaluates electromagnetic tracking for femoral derotation to improve these results.
The patients are recruited from the outpatients department and included if they meet the criteria.
A baseline rotational CT or MRI scan and a 3D gait analysis are performed preoperatively. The patients are randomized into a electromagnetic tracking group or a classical goniometer group. The derotation is measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amount of derotation more accurately.
The surgical procedure follows standard rules and does not need alterations because of the study.
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
- Single (Participant)
盲法说明
Patients are masked about which group they are randomized in
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy
- •GMFCS level I-III
- •Functionally disturbing internal rotation gait
- •Indication for femoral derotation osteotomy
排除标准
- •No capacity of consent
- •Inability to perform all needed types examinations
- •Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)
结局指标
主要结局
Comparing the mean hip rotation between the groups
时间窗: One year after surgery
Measuring the functional outcome with the mean hip rotation in stance comparing pre- and postoperative gait analysis .
Comparing the mean pelvic rotation between the groups
时间窗: One year after surgery
Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .
次要结局
- Evaluate actual amount of bony derotation(Shortly after surgery (not ore than 3 month) and again one year after surgery)
- Comparing the bony derotation between the groups(Shortly after surgery (not ore than 3 month) and again one year after surgery)
研究者
Thomas Dreher
Prof. Dr. med. Thomas Dreher
Heidelberg University