An interventional study of Femoral Derotation Osteotomy (FDO) in Gait Disorders, Neurologic, Cerebral Palsy and Malalignment, sponsored by Heidelberg University. Status unknown at 1 site in Germany. Open to participants aged 6 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment
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.
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's planned enrollment of 30 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
FDO: classic procedure with goniometer controlled derotation
Procedure: Femoral Derotation Osteotomy (FDO)
FDO: procedure with electromagnetic tracking (EMT) controlling derotation
Procedure: Femoral Derotation Osteotomy (FDO)
Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis
Comparing the mean hip rotation between the groups
Measuring the functional outcome with the mean hip rotation in stance comparing pre- and postoperative gait analysis .
Time frame: One year after surgery
Comparing the mean pelvic rotation between the groups
Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .
Time frame: One year after surgery
Evaluate actual amount of bony derotation
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan, given in degrees.
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Comparing the bony derotation between the groups
Comparing the planned amount of derotation in degrees with the intraoperative electromagnetic tracking values and the postoperative rotational MRI values in degrees to evaluate the accuracy of implementing a certain amount of bony derotation.
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Plan to share: Undecided
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Heidelberg University