Interal Rotation GaitNCT03528889
Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking
A study testing Femoral Extension and Derotation Osteotomy (ExtFDO) in people with Interal Rotation Gait and Crouch Gait, run by Heidelberg University at 1 site in Germany.
Trial summary
The study is designed to evaluate the use of electromagnetic tracking in multi plane femoral osteotomies, namely extension derotation osteotomies. The goal is to raise the precision of the surgical procedure in order to improve the outcome in short- and long term. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Interal Rotation Gait, Crouch Gait, Cerebral Palsy
- What is being tested?
- Femoral Extension and Derotation Osteotomy (ExtFDO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral palsy
- GMFCS level I-III
- Functionally disturbing internal rotation gait
- Indication for femoral derotation osteotomy
Who cannot join
- No capacity of consent
- Inability to perform all needed types examinations
- Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)
Trial locations and contacts
1 site in 1 country.
Marco Götze, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Orthopedic Department, University of Heidelberg
Heidelberg, 69118
Thomas Dreher, Prof. Dr., +4962215625000, thomas.dreher@med.uni-heidelberg.de
Marco Götze, Dr., marco.goetze@med.uni-heidelberg.de
About this study
Official title: Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
The study is designed to evaluate the use of electromagnetic tracking in multi plane femoral osteotomies, namely extension 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.
Read the detailed description
Internal rotation crouch gait is a common deformity in patients with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral extension and 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 amount of extension and/or derotation in OR.
The study now evaluates electromagnetic tracking for femoral extension and 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 extension and derotation are measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amounts of extension and derotation more accurately.
The surgical procedure follows standard rules and does not need alterations because of the study.
After the operation a second CT or MRI scan is performed and the extension and derotation are 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
- Interal Rotation Gait, Crouch Gait, Cerebral Palsy, Malalignment
- Being tested
- Femoral Extension and Derotation Osteotomy (ExtFDO)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Extension and Derotation Osteotomy (ExtFDO)Procedure or surgery
Correction of malrotation of the femoral bone and flexed knee gait by osteotomy, derotation and osteosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Goniometer | Active comparator | Extension FDO: classic procedure with goniometer controlled extension and derotation Receives: Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO) |
| EMT | Experimental | Extension FDO: procedure with electromagnetic tracking (EMT) controlling extension and derotation Receives: Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the mean hip rotation between the groups
Measuring the functional outcome with the mean hip rotation comparing pre- and postoperative gait analysis of the patients.
Measured: One year after surgery
Comparing the minimum knee flexion in stance phase between the groups
Measuring the functional outcome with the minimum knee flexion in stance phase comparing pre- and postoperative gait analysis of the patients.
Measured: One year after surgery
Comparing the anterior pelvic tilt between the groups
Measuring the functional outcome with the anterior pelvic tilt comparing pre- and postoperative gait analysis of the patients.
Measured: One year after surgery
Comparing the pelvic rotation between the groups
Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.
Measured: One year after surgery
Secondary outcomes (4)
Comparing the bony derotation between the groups
Measuring the actual amount of derotation in degrees in a postoperative CT or MRI scan.
Measured: Shortly after surgery (not ore than 3 month) and again one year after surgery
Comparing the bony extension between the groups
Measuring the actual amount of extension in degrees in a postoperative CT or MRI scan.
Measured: Shortly after surgery (not ore than 3 month) and again one year after surgery
Evaluate the accuracy of bony derotation between the groups
Comparing the 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.
Measured: Shortly after surgery (not ore than 3 month) and again one year after surgery
Evaluate the accuracy of bony extension between the groups
Comparing the the planned amount of extension 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 extension.
Measured: Shortly after surgery (not ore than 3 month) and again one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Dec 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interal Rotation GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into two study arms: 1. Classic control of extension and derotation using a Moeltgen goniometer intraoperatively 2. Control of extension and derotation using an electromagnetic tracking device intraoperatively
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Responsible party
- Principal investigator, Thomas Dreher, Heidelberg University
- Investigators
- Thomas Dreher, Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528889
- Sponsor's protocol ID
- InstruExtensionFDO
- Status last verified
- Apr 2020
- First submitted
- 20 Dec 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28419537Geisbusch 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.
PubMed 27325569
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Femoral Extension and Derotation Osteotomy In Cerebral Palsy With Electromagnetic Tracking - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03528889
- Acronym / sponsor ID
- InstruExtensionFDO
- Conditions
- Interal Rotation Gait, Crouch Gait, Cerebral Palsy, Malalignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the use of electromagnetic tracking in multi plane femoral osteotomies, namely extension 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 crouch gait is a common deformity in patients with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral extension and 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 amount of extension and/or derotation in OR.
The study now evaluates electromagnetic tracking for femoral extension and 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 extension and derotation are measured with the EMT system or with a classic Moeltgen goniometer in the OR. Goal is to achieve the planned amounts of extension and derotation more accurately.
The surgical procedure follows standard rules and does not need alterations because of the study.
After the operation a second CT or MRI scan is performed and the extension and derotation are 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization into two study arms: 1. Classic control of extension and derotation using a Moeltgen goniometer intraoperatively 2. Control of extension and derotation using an electromagnetic tracking device intraoperatively
| Arm | Type | Receives |
|---|---|---|
| Goniometer | Active comparator | Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)Extension FDO: classic procedure with goniometer controlled extension and derotation |
| EMT | Experimental | Procedure: Femoral Extension and Derotation Osteotomy (ExtFDO)Extension FDO: procedure with electromagnetic tracking (EMT) controlling extension and derotation |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Cerebral palsy
- GMFCS level I-III
- Functionally disturbing internal rotation gait
- Indication for femoral derotation osteotomy
Key exclusion criteria (3 listed)
- No capacity of consent
- Inability to perform all needed types examinations
- Minors: Inability of getting a MRI rotational scan (i.e. pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral Extension and Derotation Osteotomy (ExtFDO)Correction of malrotation of the femoral bone and flexed knee gait by osteotomy, derotation and osteosynthesis | Procedure or surgery | EMT, Goniometer |
Primary outcome
Comparing the mean hip rotation between the groups
Time frame: One year after surgery
Measuring the functional outcome with the mean hip rotation comparing pre- and postoperative gait analysis of the patients.
Comparing the minimum knee flexion in stance phase between the groups
Time frame: One year after surgery
Measuring the functional outcome with the minimum knee flexion in stance phase comparing pre- and postoperative gait analysis of the patients.
Comparing the anterior pelvic tilt between the groups
Time frame: One year after surgery
Measuring the functional outcome with the anterior pelvic tilt comparing pre- and postoperative gait analysis of the patients.
Comparing the pelvic rotation between the groups
Time frame: One year after surgery
Measuring the functional outcome with the pelvic rotation comparing pre- and postoperative gait analysis of the patients.
4 secondary outcomes
Comparing the bony derotation between the groups
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Comparing the bony extension between the groups
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Evaluate the accuracy of bony derotation between the groups
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Evaluate the accuracy of bony extension between the groups
Time frame: Shortly after surgery (not ore than 3 month) and again one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Background: PubMed 28419537Geisbusch 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.
- Background: PubMed 27325569Geisbusch 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Götze, Dr. contact
Thomas Dreher study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Extension and Derotation Osteotomy (ExtFDO) in people with Interal Rotation Gait and Crouch Gait, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Dreher, Prof. Dr. (+4962215625000, thomas.dreher@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the mean hip rotation between the groups (time frame: One year after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528889, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.