Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Malalignment; Interal Rotation Gait; Crouch Gait
• Intervention / Treatment: Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)

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.

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

Contacts and Locations

• Study Contact: Name: Thomas Dreher, Prof. Dr.; Phone Number: +4962215625000; Email: thomas.dreher@med.uni-heidelberg.de
• Study Contact Backup: Name: Marco Götze, Dr.; Email: marco.goetze@med.uni-heidelberg.de

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; Extension FDO: classic procedure with goniometer controlled extension and derotation	Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO); Correction of malrotation of the femoral bone and flexed knee gait by osteotomy, derotation and osteosynthesis
Experimental: EMT; Extension FDO: procedure with electromagnetic tracking (EMT) controlling extension and derotation	Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO); Correction of malrotation of the femoral bone and flexed knee gait 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 comparing pre- and postoperative gait analysis of the patients.	One year after surgery
Comparing the minimum knee flexion in stance phase between the groups	Measuring the functional outcome with the minimum knee flexion in stance phase comparing pre- and postoperative gait analysis of the patients.	One year after surgery
Comparing the anterior pelvic tilt between the groups	Measuring the functional outcome with the anterior pelvic tilt comparing pre- and postoperative gait analysis of the patients.	One year after surgery
Comparing the pelvic rotation between the groups	Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.	One year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the bony derotation between the groups	Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan.	Shortly after surgery (not ore than 3 month) and again one year after surgery
Comparing the bony extension between the groups	Measuring the actual amount of extension in degrees in a postoperative CT or MRI scan.	Shortly after surgery (not ore than 3 month) and again one year after surgery
Evaluate the accuracy of bony derotation between the groups	Comparing the 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
Evaluate the accuracy of bony extension between the groups	Comparing the the planned amount of extension 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 extension.	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, 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 18, 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; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: InstruExtensionFDO

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