Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Palsy
  • Gait Disorders, Neurologic
  • Malalignment
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization into two study arms: Classic control of derotation using a Moeltgen goniometer intraoperatively Control of 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 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. Non...

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. After the operation a second rotational CT or MRI scan is performed and the derotation 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 #
NCT03518541
Collaborators
Else Kröner Fresenius Foundation
Investigators
Study Director: Thomas Dreher, Prof. Dr. University Hospital Heidelberg