Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking
1 other identifier
interventional
20
1 country
1
Brief Summary
The study is designed to evaluate the use of electromagnetic tracking in 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. The electromagnetic tracking system is evaluated against a base line CT scan serving as reference standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 15, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 29, 2016
November 1, 2016
4 years
November 15, 2016
November 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
The study evaluates the result of the derotation measurement by the EMT system against the derotation in degrees that is measured with the difference between the pre- and the post-operative CT scan (meaning: EMT measurement intra-operative versus difference in femoral rotation in the CT scan between pre- and post-operative CT). The outcome is given in degrees.
After the postoperative CT Scan (maximum of three month after surgery)
Study Arms (1)
EMT Arm
OTHERThe study is performed with a single arm, as the system is an additional tool for derotation measurement and the surgical procedure itself and its technique is not changed.
Interventions
Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit
Eligibility Criteria
You may qualify if:
- functionally impairing internal rotation gait and indication for supracondylar derotation osteotomy (Evidence of falling because of internal rotation gait, abnormally increased femoral anteversion, confirmation of internal rotation gait in gait kinematics of hip rotation and foot progression angle and a mid point shift in the clinical examination).
You may not qualify if:
- severe mental retardation and inability to undertake the CT scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic Department, University of Heidelberg
Heidelberg, 69118, Germany
Related Publications (1)
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Dreher, Dr.
MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 15, 2016
First Posted
November 29, 2016
Study Start
July 1, 2013
Primary Completion
July 1, 2017
Study Completion
October 1, 2017
Last Updated
November 29, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share