Interna Rotation GaitNCT02976532
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking
A study testing Electromagnetic tracking unit in femoral derotation surgery in people with Interna Rotation Gait and Cerebral Palsy, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Interna Rotation Gait, Cerebral Palsy, Malrotation; Bone
- What is being tested?
- Electromagnetic tracking unit in femoral derotation surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Oct 2017
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- severe mental retardation and inability to undertake the CT scan
Trial locations and contacts
1 site in 1 country.
Thomas Dreher, Dr. contact
Andreas Geisbüsch, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Orthopaedic Department, University of Heidelberg
Heidelberg, 69118
Thomas Dreher, Dr., thomas.dreher@med.uni-heidelberg.de
Andreas Geisbüsch, Dr., andreas.geisbuesch@med.uni-heidelberg.de
About this study
Official title: Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study
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.
Read the 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.
- Conditions
- Interna Rotation Gait, Cerebral Palsy, Malrotation; Bone, In-toing
- Being tested
- Electromagnetic tracking unit in femoral derotation surgery
- Keywords
- Electromagnetic tracking, Internal rotation gait, Femoral derotation osteotomy
- Medical subject headings
- Cerebral Palsy, Volvulus Of Midgut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic tracking unit in femoral derotation surgeryOther
Also called A self developed software interface, EMT pointer device (FlexPointer E01 2002, fiagon GmbH, Berlin, Germany) for surface sampling, EMT sensors embedded in a clamp shell (PointerShell E01 2902, fiagon GmbH, Berlin, Germany), A field generator (AURORA v.2, Northern Digital, Waterloo, Canada)
Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit
| Study group | Role | What they receive |
|---|---|---|
| EMT Arm | Other | The study is performed with a single arm, as the system is an additional tool for derotation measurement and the surgical procedure itself and its technique is not changed. Receives: Other: Electromagnetic tracking unit in femoral derotation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
The study evaluates the result of the derotation measurement by the EMT system against the derotation in degrees that is measured with the difference between the pre- and the post-operative CT scan (meaning: EMT measurement intra-operative versus difference in femoral rotation in the CT scan between pre- and post-operative CT). The outcome is given in degrees.
Measured: After the postoperative CT Scan (maximum of three month after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interna 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Dreher, Heidelberg University
- Investigators
- Thomas Dreher, Dr., Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976532
- Sponsor's protocol ID
- NavDo2014
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27325569
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study
- ClinicalTrials.gov ID
- NCT02976532
- Acronym / sponsor ID
- NavDo2014
- Conditions
- Interna Rotation Gait, Cerebral Palsy, Malrotation; Bone, In-toing
- Keywords
- Electromagnetic tracking, Internal rotation gait, Femoral derotation osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMT Arm | Other | Other: Electromagnetic tracking unit in femoral derotation surgeryThe study is performed with a single arm, as the system is an additional tool for derotation measurement and the surgical procedure itself and its technique is not changed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- severe mental retardation and inability to undertake the CT scan
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 |
|---|---|---|
| Electromagnetic tracking unit in femoral derotation surgeryAlso: A self developed software interface, EMT pointer device (FlexPointer E01 2002, fiagon GmbH, Berlin, Germany) for surface sampling, EMT sensors embedded in a clamp shell (PointerShell E01 2902, fiagon GmbH, Berlin, Germany), A field generator (AURORA v.2, Northern Digital, Waterloo, Canada)Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit | Other | EMT Arm |
Primary outcome
Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
Time frame: After the postoperative CT Scan (maximum of three month after surgery)
The study evaluates the result of the derotation measurement by the EMT system against the derotation in degrees that is measured with the difference between the pre- and the post-operative CT scan (meaning: EMT measurement intra-operative versus difference in femoral rotation in the CT scan between pre- and post-operative CT). The outcome is given in degrees.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- 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: No
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.
Thomas Dreher, Dr. contact
Andreas Geisbüsch, Dr. contact
Thomas Dreher, Dr. principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic tracking unit in femoral derotation surgery in people with Interna Rotation Gait and Cerebral Palsy, 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 1 inclusion and 1 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 29 Nov 2016. 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, Dr. (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?
Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees (time frame: After the postoperative CT Scan (maximum of three month after surgery)). 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 NCT02976532, which also lists 1 linked publication.
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 29 Nov 2016.