Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
Primary Purpose
Gait Disorders, Neurologic, Cerebral Palsy, Malalignment
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Femoral Derotation Osteotomy (FDO)
Sponsored by
About this trial
This is an interventional treatment trial for Gait Disorders, Neurologic
Eligibility 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)
Sites / Locations
- Orthopedic Department, University of HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Goniometer
EMT
Arm Description
FDO: classic procedure with goniometer controlled derotation
FDO: procedure with electromagnetic tracking (EMT) controlling derotation
Outcomes
Primary Outcome Measures
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 .
Comparing the mean pelvic rotation between the groups
Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .
Secondary Outcome Measures
Evaluate actual amount of bony derotation
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan, given in degrees.
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.
Full Information
NCT ID
NCT03518541
First Posted
December 20, 2017
Last Updated
April 1, 2020
Sponsor
Heidelberg University
Collaborators
Else Kröner Fresenius Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03518541
Brief Title
Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
Official Title
Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Else Kröner Fresenius Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic, Cerebral Palsy, Malalignment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization into two study arms:
Classic control of derotation using a Moeltgen goniometer intraoperatively
Control of derotation using an electromagnetic tracking device intraoperatively
Masking
Participant
Masking Description
Patients are masked about which group they are randomized in
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Goniometer
Arm Type
Active Comparator
Arm Description
FDO: classic procedure with goniometer controlled derotation
Arm Title
EMT
Arm Type
Experimental
Arm Description
FDO: procedure with electromagnetic tracking (EMT) controlling derotation
Intervention Type
Procedure
Intervention Name(s)
Femoral Derotation Osteotomy (FDO)
Intervention Description
Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis
Primary Outcome Measure Information:
Title
Comparing the mean hip rotation between the groups
Description
Measuring the functional outcome with the mean hip rotation in stance comparing pre- and postoperative gait analysis .
Time Frame
One year after surgery
Title
Comparing the mean pelvic rotation between the groups
Description
Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .
Time Frame
One year after surgery
Secondary Outcome Measure Information:
Title
Evaluate actual amount of bony derotation
Description
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan, given in degrees.
Time Frame
Shortly after surgery (not ore than 3 month) and again one year after surgery
Title
Comparing the bony derotation between the groups
Description
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.
Time Frame
Shortly after surgery (not ore than 3 month) and again one year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Dreher, Prof. Dr.
Phone
+4962215625000
Email
thomas.dreher@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Götze, Dr.
Email
marco.goetze@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dreher, Prof. Dr.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic Department, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69118
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Dreher, Prof. Dr.
Phone
+4962215625000
Email
thomas.dreher@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Marco Götze, Dr.
Email
marco.goetze@med.uni-heidelberg.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28419537
Citation
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.
Results Reference
background
PubMed Identifier
27325569
Citation
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.
Results Reference
background
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Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
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