Clinical trial NCT02976532: Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking
Official title: Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interna Rotation Gait
Cerebral Palsy
Malrotation; Bone
In-toing
Keywords: Electromagnetic tracking
Internal rotation gait
Femoral derotation osteotomy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
timeFrame: After the postoperative CT Scan (maximum of three month after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Orthopaedic Department, University of Heidelberg
Study officials:
affiliation: MD
name: Thomas Dreher, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.