NCT03518541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 2, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

December 20, 2017

Last Update Submit

April 1, 2020

Conditions

Gait Disorders, NeurologicCerebral PalsyMalalignment

Outcome Measures

Primary Outcomes (2)

  • 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 .

    One year after surgery

  • Comparing the mean pelvic rotation between the groups

    Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis .

    One year after surgery

Secondary Outcomes (2)

  • Evaluate actual amount of bony derotation

    Shortly after surgery (not ore than 3 month) and again one year after surgery

  • Comparing the bony derotation between the groups

    Shortly after surgery (not ore than 3 month) and again one year after surgery

Study Arms (2)

Goniometer

ACTIVE COMPARATOR

FDO: classic procedure with goniometer controlled derotation

Procedure: Femoral Derotation Osteotomy (FDO)

EMT

EXPERIMENTAL

FDO: procedure with electromagnetic tracking (EMT) controlling derotation

Procedure: Femoral Derotation Osteotomy (FDO)

Interventions

Femoral Derotation Osteotomy (FDO)PROCEDURE

Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis

EMTGoniometer

Eligibility Criteria

Age6 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cerebral palsy
  • GMFCS level I-III
  • Functionally disturbing internal rotation gait
  • Indication for femoral derotation osteotomy

You may not qualify if:

  • No capacity of consent
  • Inability to perform all needed types examinations
  • Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Department, University of Heidelberg

Heidelberg, 69118, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28419537BACKGROUND

  • 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.

    PMID: 27325569BACKGROUND

MeSH Terms

Conditions

Gait Disorders, NeurologicCerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Thomas Dreher, Prof. Dr.

    University Hospital Heidelberg

    STUDY DIRECTOR

Central Study Contacts

Thomas Dreher, Prof. Dr.

CONTACT

+4962215625000thomas.dreher@med.uni-heidelberg.de

Marco Götze, Dr.

CONTACT

marco.goetze@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients are masked about which group they are randomized in
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Thomas Dreher

Study Record Dates

First Submitted

December 20, 2017

First Posted

May 8, 2018

Study Start

December 1, 2017

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

April 2, 2020

Record last verified: 2020-04

Locations

DE(1)