Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-17 @ 2:07 AM
Study NCT ID:
NCT02976532
Status:
UNKNOWN
Last Update Posted:
2016-11-29
First Post:
2016-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking
Sponsor:
Heidelberg University
Organization:
Study Overview
Official Title:
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: