Clinical trial NCT03528889: Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
Official title: Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interal Rotation Gait
Crouch Gait
Cerebral Palsy
Malalignment
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2018-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into two study arms:

1. Classic control of extension and derotation using a Moeltgen goniometer intraoperatively
2. Control of extension and derotation using an electromagnetic tracking device intraoperatively
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the use of electromagnetic tracking in multi plane femoral osteotomies, namely extension 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.

Detailed 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. 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.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy
* GMFCS level I-III
* Functionally disturbing internal rotation gait
* Indication for femoral derotation osteotomy

Exclusion Criteria:

* No capacity of consent
* Inability to perform all needed types examinations
* Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)

Primary outcomes:
measure: Comparing the mean hip rotation between the groups
timeFrame: One year after surgery
measure: Comparing the minimum knee flexion in stance phase between the groups
timeFrame: One year after surgery
measure: Comparing the anterior pelvic tilt between the groups
timeFrame: One year after surgery
measure: Comparing the pelvic rotation between the groups
timeFrame: One year after surgery
Secondary outcomes:
measure: Comparing the bony derotation between the groups
timeFrame: Shortly after surgery (not ore than 3 month) and again one year after surgery
measure: Comparing the bony extension between the groups
timeFrame: Shortly after surgery (not ore than 3 month) and again one year after surgery
measure: Evaluate the accuracy of bony derotation between the groups
timeFrame: Shortly after surgery (not ore than 3 month) and again one year after surgery
measure: Evaluate the accuracy of bony extension between the groups
timeFrame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Orthopedic Department, University of Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Thomas Dreher
role: STUDY_DIRECTOR
References:
citation: Geisbusch A, Auer C, Dickhaus H, Putz C, Dreher T. Electromagnetic tracking for femoral derotation osteotomy-an in vivo study. J Orthop Res. 2017 Dec;35(12):2652-2657. doi: 10.1002/jor.23579. Epub 2017 May 23.
citation: Geisbusch A, Auer C, Dickhaus H, Niklasch M, Dreher T. Electromagnetic bone segment tracking to control femoral derotation osteotomy-A saw bone study. J Orthop Res. 2017 May;35(5):1106-1112. doi: 10.1002/jor.23348. Epub 2016 Jul 4.