Clinical Trial: Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Heidelberg University

Current Primary Outcome: Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees [ Time Frame: After the postoperative CT Scan (maximum of three month after surgery) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Heidelberg University

Dates:
Date Received: November 15, 2016
Date Started: July 2013
Date Completion: October 2017
Last Updated: November 28, 2016
Last Verified: November 2016