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

NCT03528889 | Unknown

• 1 other identifier: InstruExtensionFDO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interal Rotation Gait; Crouch Gait; Cerebral Palsy; Malalignment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Comparing the bony derotation between the groups

  Shortly after surgery (not ore than 3 month) and again one year after surgery

• Comparing the bony extension between the groups

  Shortly after surgery (not ore than 3 month) and again one year after surgery

• Evaluate the accuracy of bony derotation between the groups

  Shortly after surgery (not ore than 3 month) and again one year after surgery

• Evaluate the accuracy of bony extension between the groups

  Shortly after surgery (not ore than 3 month) and again one year after surgery

Study Arms (2)

Goniometer

ACTIVE COMPARATOR

Extension FDO: classic procedure with goniometer controlled extension and derotation

Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)

EMT

EXPERIMENTAL

Extension FDO: procedure with electromagnetic tracking (EMT) controlling extension and derotation

Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)

Interventions

Femoral Extension and Derotation Osteotomy (ExtFDO) PROCEDURE

Correction of malrotation of the femoral bone and flexed knee gait by osteotomy, derotation and osteosynthesis

EMT; Goniometer

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead
• Else Kröner Fresenius Foundation: collaborator

Study Sites (1)

Orthopedic Department, University of Heidelberg

Heidelberg, 69118, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 28419537 BACKGROUND

• 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.

  PMID: 27325569 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas Dreher

  University Hospital Heidelberg

  STUDY DIRECTOR

Central Study Contacts

Thomas Dreher, Prof. Dr.

CONTACT

+4962215625000; thomas.dreher@med.uni-heidelberg.de

Marco Götze, Dr.

CONTACT

marco.goetze@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are masked about which group they are randomized in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Thomas Dreher

Model Details: 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

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: May 18, 2018
• Study Start: December 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 2, 2020

Record last verified: 2020-04

Locations

DE (1)