Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Malalignment
• Intervention / Treatment: Procedure: Femoral Derotation Osteotomy (FDO)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69118
    • Recruiting
    • Orthopedic Department, University of Heidelberg
    • Contact: Thomas Dreher, Prof. Dr.; Phone Number: +4962215625000; Email: thomas.dreher@med.uni-heidelberg.de
    • Contact: Marco Götze, Dr.; Email: marco.goetze@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Goniometer; FDO: classic procedure with goniometer controlled derotation	Procedure: Femoral Derotation Osteotomy (FDO); Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis
Experimental: EMT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: Else Kröner Fresenius Foundation
• Investigators: Study Director: Thomas Dreher, Prof. Dr., University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: May 6, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: InstruFDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No