Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Interna Rotation Gait Cerebral Palsy Malrotation; Bone In-toing

Keywords

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Electromagnetic tracking Internal rotation gait Femoral derotation osteotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EMT Arm

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.

Group Type OTHER

Electromagnetic tracking unit in femoral derotation surgery

Intervention Type OTHER

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

Interventions

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Electromagnetic tracking unit in femoral derotation surgery

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

Intervention Type OTHER

Other Intervention Names

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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)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Thomas Dreher

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Dreher, Dr.

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Orthopaedic Department, University of Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Dreher, Dr.

Role: CONTACT

Email: [email protected]

Andreas Geisbüsch, Dr.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Thomas Dreher, Dr.

Role: primary

Andreas Geisbüsch, Dr.

Role: backup

References

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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.

Reference Type BACKGROUND

PMID: 27325569 (View on PubMed)

Other Identifiers

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NavDo2014

Identifier Type: -

Identifier Source: org_study_id

Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

EMT Arm

Electromagnetic tracking unit in femoral derotation surgery

Interventions

Electromagnetic tracking unit in femoral derotation surgery

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Heidelberg University

Responsible Party

Thomas Dreher

Principal Investigators

Thomas Dreher, Dr.

Locations

Orthopaedic Department, University of Heidelberg

Countries

Central Contacts

Thomas Dreher, Dr.

Andreas Geisbüsch, Dr.

Facility Contacts

Thomas Dreher, Dr.

Andreas Geisbüsch, Dr.

References

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.

Other Identifiers

NavDo2014