Controlling Femoral Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking

NCT ID: NCT03518541

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-12-31

Brief Summary

The study is designed to evaluate the use of electromagnetic tracking in transversal plane 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. All patients are examined with an instrumented 3D gait analysis pre- and one year postoperatively. The electromagnetic tracking system is evaluated against a base line CT or MRI scan serving as reference standard pre- and postoperatively.

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 or MRI scan and a 3D gait analysis are performed preoperatively. The patients are randomized into a electromagnetic tracking group or a classical goniometer group. The derotation is measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amount of derotation more accurately.

The surgical procedure follows standard rules and does not need alterations because of the study.

After the operation a second rotational CT or MRI scan is performed and the derotation precisely evaluated by two raters and later compared to the results of the intraoperative electromagnetic tracking system. One year postoperative a second 3D gait analysis is performed to measure and compare the functional and dynamic outcome.

Conditions

Gait Disorders, Neurologic; Cerebral Palsy; Malalignment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Goniometer

FDO: classic procedure with goniometer controlled derotation

Group Type: ACTIVE_COMPARATOR

Femoral Derotation Osteotomy (FDO)

Intervention Type: PROCEDURE

Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis

EMT

FDO: procedure with electromagnetic tracking (EMT) controlling derotation

Group Type: EXPERIMENTAL

Femoral Derotation Osteotomy (FDO)

Intervention Type: PROCEDURE

Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis

Interventions

Femoral Derotation Osteotomy (FDO)

Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Cerebral palsy
• GMFCS level I-III
• Functionally disturbing internal rotation gait
• Indication for femoral derotation osteotomy

Exclusion Criteria

• No capacity of consent
• Inability to perform all needed types examinations
• Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Else Kröner Fresenius Foundation

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Dreher

Prof. Dr. med. Thomas Dreher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Dreher, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Heidelberg

Locations

Orthopedic Department, University of Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Dreher, Prof. Dr.

Role: CONTACT

thomas.dreher@med.uni-heidelberg.de

+4962215625000

Marco Götze, Dr.

Role: CONTACT

marco.goetze@med.uni-heidelberg.de

Facility Contacts

Thomas Dreher, Prof. Dr.

Role: primary

thomas.dreher@med.uni-heidelberg.de

+4962215625000

Marco Götze, Dr.

Role: backup

marco.goetze@med.uni-heidelberg.de

References

Geisbusch A, Auer C, Dickhaus H, Putz C, Dreher T. Electromagnetic tracking for femoral derotation osteotomy-an in vivo study. J Orthop Res. 2017 Dec;35(12):2652-2657. doi: 10.1002/jor.23579. Epub 2017 May 23.

Reference Type: BACKGROUND

PMID: 28419537 (View on PubMed)

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

InstruFDO

Identifier Type: -

Identifier Source: org_study_id