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| Name | Class |
|---|---|
| Else Kröner Fresenius Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goniometer | Active Comparator | FDO: classic procedure with goniometer controlled derotation |
|
| EMT | Experimental | FDO: procedure with electromagnetic tracking (EMT) controlling derotation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Derotation Osteotomy (FDO) | Procedure | Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the mean hip rotation between the groups | Measuring the functional outcome with the mean hip rotation in stance comparing pre- and postoperative gait analysis . | One year after surgery |
| Comparing the mean pelvic rotation between the groups | Measuring the functional outcome with the mean pelvic rotation comparing pre- and postoperative gait analysis . | One year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate actual amount of bony derotation | Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan, given in degrees. | Shortly after surgery (not ore than 3 month) and again one year after surgery |
| Comparing the bony derotation between the groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Dreher, Prof. Dr. | Contact | +4962215625000 | thomas.dreher@med.uni-heidelberg.de | |
| Marco Götze, Dr. | Contact | marco.goetze@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Dreher, Prof. Dr. | University Hospital Heidelberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Department, University of Heidelberg | Recruiting | Heidelberg | 69118 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28419537 | Background | 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. | |
| 27325569 | Background | 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. |
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| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomization into two study arms:
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Patients are masked about which group they are randomized in
Comparing the planned amount of derotation in degrees with the intraoperative electromagnetic tracking values and the postoperative rotational MRI values in degrees to evaluate the accuracy of implementing a certain amount of bony derotation. |
| Shortly after surgery (not ore than 3 month) and again one year after surgery |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |