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

Primary Purpose

Interal Rotation Gait, Crouch Gait, Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Femoral Extension and Derotation Osteotomy (ExtFDO)
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interal Rotation Gait

Eligibility Criteria

6 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Extension FDO: classic procedure with goniometer controlled extension and derotation

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Comparing the pelvic rotation between the groups
Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.

Secondary Outcome Measures

Comparing the bony derotation between the groups
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan.
Comparing the bony extension between the groups
Measuring the actual amount of extension in degrees in a postoperative CT or MRI scan.
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.
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.

Full Information

First Posted
December 20, 2017
Last Updated
April 1, 2020
Sponsor
Heidelberg University
Collaborators
Else Kröner Fresenius Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03528889
Brief Title
Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
Official Title
Controlling Femoral Extension and 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interal Rotation Gait, Crouch Gait, 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 extension and derotation using a Moeltgen goniometer intraoperatively Control of extension and 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
Extension FDO: classic procedure with goniometer controlled extension and derotation
Arm Title
EMT
Arm Type
Experimental
Arm Description
Extension FDO: procedure with electromagnetic tracking (EMT) controlling extension and derotation
Intervention Type
Procedure
Intervention Name(s)
Femoral Extension and Derotation Osteotomy (ExtFDO)
Intervention Description
Correction of malrotation of the femoral bone and flexed knee gait 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 comparing pre- and postoperative gait analysis of the patients.
Time Frame
One year after surgery
Title
Comparing the minimum knee flexion in stance phase between the groups
Description
Measuring the functional outcome with the minimum knee flexion in stance phase comparing pre- and postoperative gait analysis of the patients.
Time Frame
One year after surgery
Title
Comparing the anterior pelvic tilt between the groups
Description
Measuring the functional outcome with the anterior pelvic tilt comparing pre- and postoperative gait analysis of the patients.
Time Frame
One year after surgery
Title
Comparing the pelvic rotation between the groups
Description
Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.
Time Frame
One year after surgery
Secondary Outcome Measure Information:
Title
Comparing the bony derotation between the groups
Description
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan.
Time Frame
Shortly after surgery (not ore than 3 month) and again one year after surgery
Title
Comparing the bony extension between the groups
Description
Measuring the actual amount of extension in degrees in a postoperative CT or MRI scan.
Time Frame
Shortly after surgery (not ore than 3 month) and again one year after surgery
Title
Evaluate the accuracy of bony derotation between the groups
Description
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.
Time Frame
Shortly after surgery (not ore than 3 month) and again one year after surgery
Title
Evaluate the accuracy of bony extension between the groups
Description
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.
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
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
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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 Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

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