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

Sponsor
Heidelberg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03528889
Collaborator
Else Kröner Fresenius Foundation (Other)
30
Enrollment
1
Location
2
Arms
49
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 intraoperativelyRandomization 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:
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 :
Dec 1, 2017
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Comparing the mean hip rotation between the groups [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
6 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Orthopedic Department, University of Heidelberg Heidelberg Germany 69118

Sponsors and Collaborators

  • Heidelberg University
  • Else Kröner Fresenius Foundation

Investigators

  • Study Director: Thomas Dreher, University Hospital Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thomas Dreher, Prof. Dr. Thomas Dreher, Heidelberg University
ClinicalTrials.gov Identifier:
NCT03528889
Other Study ID Numbers:
  • InstruExtensionFDO
First Posted:
May 18, 2018
Last Update Posted:
Apr 2, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
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

Study Results

No Results Posted as of Apr 2, 2020