Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

Cerebral Palsy Clinical Trial

Official title:

Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02976532
• Other study ID #: NavDo2014
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 28, 2016
• Start date: July 2013
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: Heidelberg University
• Contact: Thomas Dreher, Dr.
• Email: thomas.dreher[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebral Palsy
• In-toing
• Interna Rotation Gait
• Malrotation; Bone

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Orthopaedic Department, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Geisbüsch 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. 2016 Jun 21. doi: 10.1002/jor.23348. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No