Hip FracturePhase 4NCT00955565
Accuracy of Navigation in Placement of Sacroiliac Screw
A Phase 4 study testing Navigated and Conventional in people with Hip Fracture, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 3 countries.
Trial summary
The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Navigated and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jun 2008to Jan 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically confirmed sacroiliac dislocation or sacroiliac fracture
- Sacroiliac arthritis
- Age 18 years and more
- Written informed consent by patient or his/her legal representative
Who cannot join
- Poor life expectancy (<3months)
- Fracture of pathologic origin
- History of substance abuse (recreational drugs, alcohol)within 12 months prior to screening
- Prisoner
- Currently involved in another study that precludes or complicates participation
- Disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany7 sites
Charité Berlin, Campus Virchow Klinikum
Berlin, 13353
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum des Saarlandes
Homburg, 66421
Klinikum rechts der Isar der TU München
München, 81675
Universitätsklinikum Münster
Münster, 48149
Katharinenhospital
Stuttgart, 70174
Universität Ulm
Ulm, 89075
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908-0159
About this study
Official title: Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial
The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.
Read the detailed description
Standard treatment for sacroiliac dislocations and sacroiliac fractures is placement of two screws through the iliosacral joint into the sacral ala or the body of the S1 vertebra. Correct positioning is technically demanding. Screw displacement may reduce the strength of fixation and lead to neurological complications.
Secondary objectives of the study are to compare the fluoroscopy time, complications and surgery duration between the treatments.
- Conditions
- Hip Fracture
- Being tested
- Navigated, Conventional
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigatedProcedure or surgery
Also called BrainLab Vector Vision®Trauma Navigation Software
Subjects receive receive computer assisted placement of the sacroiliac screws. The computer assisted placement will be performed by using the BrainLab Vector Vision®Trauma Navigation Software. Two approaches will be used, the 2D navigation and 3D navigation.
ConventionalProcedure or surgery
Subjects receive standard fluoroscopic placement of the sacroiliac screw.
| Study group | Role | What they receive |
|---|---|---|
| Navigated | Experimental | Not described Receives: Procedure: Navigated |
| Conventional | Active comparator | Not described Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
Measured: 2 days
Secondary outcomes (1)
Fluoroscopic time, complications and surgery duration.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Investigators
- Beate P. Hanson, MD, Study director, AO Clinical Investigation and Documentation, Davos, SwitzerlandUlrich C. Stöckle, Prof. MD, Principal investigator, Klinikum rechts der Isar der TU München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955565
- Sponsor's protocol ID
- Sacroliac screw-08
- Status last verified
- Jan 2010
- First submitted
- 17 Jul 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Navigation in Placement of Sacroiliac Screw. Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00955565
- Acronym / sponsor ID
- Sacroliac screw-08
- Conditions
- Hip Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Aug 2009 (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 purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.
Detailed description
Standard treatment for sacroiliac dislocations and sacroiliac fractures is placement of two screws through the iliosacral joint into the sacral ala or the body of the S1 vertebra. Correct positioning is technically demanding. Screw displacement may reduce the strength of fixation and lead to neurological complications.
Secondary objectives of the study are to compare the fluoroscopy time, complications and surgery duration between the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigated | Experimental | Procedure: Navigated |
| Conventional | Active comparator | Procedure: Conventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radiologically confirmed sacroiliac dislocation or sacroiliac fracture
- Sacroiliac arthritis
- Age 18 years and more
- Written informed consent by patient or his/her legal representative
Key exclusion criteria (6 listed)
- Poor life expectancy (<3months)
- Fracture of pathologic origin
- History of substance abuse (recreational drugs, alcohol)within 12 months prior to screening
- Prisoner
- Currently involved in another study that precludes or complicates participation
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 |
|---|---|---|
| NavigatedAlso: BrainLab Vector Vision®Trauma Navigation SoftwareSubjects receive receive computer assisted placement of the sacroiliac screws. The computer assisted placement will be performed by using the BrainLab Vector Vision®Trauma Navigation Software. Two approaches will be used, the 2D navigation and 3D navigation. | Procedure or surgery | Navigated |
| ConventionalSubjects receive standard fluoroscopic placement of the sacroiliac screw. | Procedure or surgery | Conventional |
Primary outcome
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning.
Time frame: 2 days
1 secondary outcome
Fluoroscopic time, complications and surgery duration.
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2010.
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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.
Beate P. Hanson, MD study director
AO Clinical Investigation and Documentation, Davos, Switzerland
Ulrich C. Stöckle, Prof. MD principal investigator
Klinikum rechts der Isar der TU München
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Navigated and Conventional in people with Hip Fracture, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 3 countries.
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 6 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: finished, as of the sponsor's last update on 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United States, United Arab Emirates. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of misplaced sacroiliac screws as evaluated by postop CT-scanning. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2010.