Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

Cerebral Palsy Clinical Trial

Official title:

Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518541
• Other study ID #: InstruFDO
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: Thomas Dreher, Prof. Dr.
• Phone: +4962215625000
• Email: thomas.dreher[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Malalignment
• Nervous System Diseases

Intervention

Procedure:
• Femoral Derotation Osteotomy (FDO)
Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis

Locations

Country	Name	City	State
Germany	Orthopedic Department, University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Else Kröner Fresenius Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Geisbüsch 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. — View Citation

Geisbüsch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	One year after surgery
Primary	Comparing the mean pelvic rotation between the groups	Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .	One year after surgery
Secondary	Evaluate actual amount of bony derotation	Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan, given in degrees.	Shortly after surgery (not ore than 3 month) and again one year after surgery
Secondary	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.	Shortly after surgery (not ore than 3 month) and again one year after surgery