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Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

Primary Purpose

Interna Rotation Gait, Cerebral Palsy, Malrotation; Bone

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electromagnetic tracking unit in femoral derotation surgery
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interna Rotation Gait focused on measuring Electromagnetic tracking, Internal rotation gait, Femoral derotation osteotomy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • severe mental retardation and inability to undertake the CT scan

Sites / Locations

  • Orthopaedic Department, University of HeidelbergRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EMT Arm

Arm Description

The 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
November 28, 2016
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT02976532
Brief Title
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking
Official Title
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 scan and a 3-D-gait analysis are performed and the derotation measured with the EMT system in OR. The results of the measurement is invisible and unknown to the surgeon as the system unit is controlled by a technician. The surgical procedure follows standard rules and does not need alterations because of the study. After the operation a second rotational CT scan is performed and the derotation precisely evaluated by two raters and later compared to the results of the electromagnetic tracking system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interna Rotation Gait, Cerebral Palsy, Malrotation; Bone, In-toing
Keywords
Electromagnetic tracking, Internal rotation gait, Femoral derotation osteotomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMT Arm
Arm Type
Other
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
Electromagnetic tracking unit in femoral derotation surgery
Other Intervention Name(s)
A self developed software interface, EMT pointer device (FlexPointer E01 2002, fiagon GmbH, Berlin, Germany) for surface sampling, EMT sensors embedded in a clamp shell (PointerShell E01 2902, fiagon GmbH, Berlin, Germany), A field generator (AURORA v.2, Northern Digital, Waterloo, Canada)
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
Description
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.
Time Frame
After the postoperative CT Scan (maximum of three month after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: severe mental retardation and inability to undertake the CT scan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Dreher, Dr.
Email
thomas.dreher@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Geisbüsch, Dr.
Email
andreas.geisbuesch@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dreher, Dr.
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic 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, Dr.
Email
thomas.dreher@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Andreas Geisbüsch, Dr.
Email
andreas.geisbuesch@med.uni-heidelberg.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
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Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

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