Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528889
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by (Responsible Party):
Thomas Dreher, Heidelberg University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Interal Rotation Gait Crouch Gait Cerebral Palsy Malalignment Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Masking Description: Patients are masked about which group they are randomized in
Primary Purpose: Treatment
Official Title: Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Comparing the mean hip rotation between the groups [ Time Frame: One year after surgery ]
    Measuring the functional outcome with the mean hip rotation comparing pre- and postoperative gait analysis of the patients.

  2. Comparing the minimum knee flexion in stance phase between the groups [ Time Frame: One year after surgery ]
    Measuring the functional outcome with the minimum knee flexion in stance phase comparing pre- and postoperative gait analysis of the patients.

  3. Comparing the anterior pelvic tilt between the groups [ Time Frame: One year after surgery ]
    Measuring the functional outcome with the anterior pelvic tilt comparing pre- and postoperative gait analysis of the patients.

  4. Comparing the pelvic rotation between the groups [ Time Frame: One year after surgery ]
    Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.


Secondary Outcome Measures :
  1. Comparing the bony derotation between the groups [ Time Frame: Shortly after surgery (not ore than 3 month) and again one year after surgery ]
    Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan.

  2. Comparing the bony extension between the groups [ Time Frame: Shortly after surgery (not ore than 3 month) and again one year after surgery ]
    Measuring the actual amount of extension in degrees in a postoperative CT or MRI scan.

  3. Evaluate the accuracy of bony derotation between the groups [ Time Frame: Shortly after surgery (not ore than 3 month) and again one year after surgery ]
    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.

  4. Evaluate the accuracy of bony extension between the groups [ Time Frame: Shortly after surgery (not ore than 3 month) and again one year after surgery ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528889


Contacts
Layout table for location contacts
Contact: Thomas Dreher, Prof. Dr. +4962215625000 thomas.dreher@med.uni-heidelberg.de
Contact: Marco Götze, Dr. marco.goetze@med.uni-heidelberg.de

Locations
Layout table for location information
Germany
Orthopedic Department, University of Heidelberg Recruiting
Heidelberg, Germany, 69118
Contact: Thomas Dreher, Prof. Dr.    +4962215625000    thomas.dreher@med.uni-heidelberg.de   
Contact: Marco Götze, Dr.       marco.goetze@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Else Kröner Fresenius Foundation
Investigators
Layout table for investigator information
Study Director: Thomas Dreher University Hospital Heidelberg
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Thomas Dreher, Prof. Dr. Thomas Dreher, Heidelberg University
ClinicalTrials.gov Identifier: NCT03528889    
Other Study ID Numbers: InstruExtensionFDO
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases