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Trial record 92 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

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ClinicalTrials.gov Identifier: NCT03518541
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by (Responsible Party):
Thomas Dreher, Heidelberg University

Brief 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.

Condition or disease Intervention/treatment Phase
Gait Disorders, Neurologic Cerebral Palsy Malalignment Procedure: Femoral Derotation Osteotomy (FDO) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomization into two study arms:

  1. Classic control of derotation using a Moeltgen goniometer intraoperatively
  2. Control of 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 Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




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 in stance comparing pre- and postoperative gait analysis .

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


Secondary Outcome Measures :
  1. Evaluate actual amount of bony derotation [ 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, given in degrees.

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



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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)

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): NCT03518541


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

Locations
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
Study Director: Thomas Dreher, Prof. Dr. University Hospital Heidelberg

Publications:
Responsible Party: Thomas Dreher, Prof. Dr. med. Thomas Dreher, Heidelberg University
ClinicalTrials.gov Identifier: NCT03518541     History of Changes
Other Study ID Numbers: InstruFDO
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Nervous System Diseases
Gait Disorders, Neurologic
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms