Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cerebral Palsy
- Crouch Gait
- Interal Rotation Gait
- Malalignment
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization into two study arms: Classic control of extension and derotation using a Moeltgen goniometer intraoperatively Control of extension and derotation using an electromagnetic tracking device intraoperatively Masking: Single (Participant)Masking Description: Patients are masked about which group they are randomized inPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 40 years
- Gender
- Both males and females
Description
Internal rotation crouch gait is a common deformity in patients with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral extension and derotation osteotomies have proven to be effective both in short term and long term evaluation. Non...
Internal rotation crouch gait is a common deformity in patients with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral extension and 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 amount of extension and/or derotation in OR. The study now evaluates electromagnetic tracking for femoral extension and 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 extension and derotation are measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amounts of extension and derotation more accurately. The surgical procedure follows standard rules and does not need alterations because of the study. After the operation a second CT or MRI scan is performed and the extension and derotation are precisely evaluated by two raters and later compared to the results of the intraoperative electromagnetic tracking system. One year postoperative a second 3D gait analysis is performed to measure and compare the functional and dynamic outcome.
Tracking Information
- NCT #
- NCT03528889
- Collaborators
- Else Kröner Fresenius Foundation
- Investigators
- Study Director: Thomas Dreher University Hospital Heidelberg