Pelvic Ring InjuryNCT07115602
Methodology to Transfer High Volumes of Data for Distant Expert Radiographic Evaluation of Pelvic Ring Injuries
An observational study of Pelvic Ring Injury, run by Axel Gamulin.
Trial summary
The aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Ring Injury
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Adult pelvic ring injury patients operatively treated within 3 weeks from injury
Who may be able to join
- 1) admission to the author's institution between January 2012 and December 2023;
- 2) high-energy pelvic ring injury involving a non-pathologic pelvis (i.e., no prior injury, pathology, or surgery compromising image interpretation), surgically treated within three weeks of injury;
- 3) age ≥18 years at the time of trauma.
Who cannot join
- 1) imaging acquired after any kind of surgical stabilization (i.e. emergent external fixation), which could bias injury assessment;
- 2) incomplete imaging dataset, defined as the absence of any of the following: pelvic computed tomography, standard anteroposterior pelvic radiograph with pelvic binder, and standard anteroposterior pelvic radiograph without pelvic binder;
- 3) poor image quality, including incomplete pelvic coverage, computed tomography slice thickness >2 mm, motion artifacts, or incompatibility with the image viewer used for the study;
- 4) documented (written or verbal) refusal to participate.
About this study
Official title: Retrospective Multi-expert Diagnostic Imaging Evaluation of Pelvic Ring Injuries: Methodology for Transferring Large DICOM Data Volumes to Remote Experts, and Survey Designed to Isolate Information Obtained From Different Imaging Modalities
The aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. The ultimate goal was to improve the management of these injuries in both emergency and definitive treatment.
Read the detailed description
At the core of the study was a stepwise pelvic imaging evaluation of pelvic ring injury patients by a panel of international pelvic trauma experts. The assessment was conducted in 3 sequential steps:
- Review of computed tomography images alone.
- Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.
- Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.
At each step, experts independently classified the injury (Arbeitsgemeinschaft für Osteosynthsesfragen / Orthopaedic Trauma Association and Young and Burgess classifications), assessed mechanical stability and recommended definitive treatment.
- Conditions
- Pelvic Ring Injury
- Keywords
- classification, assessment, computed tomography, stability, pelvic belt, pelvic ring injury, standard anteroposterior radiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic ring injury patients with operative management within 3 weeks from injury | Pelvic ring injury patients with operative management within 3 weeks from injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification
Each expert determines the AO/OTA classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation:
- Review of computed tomography images alone;
- Addition of a standard anteroposterior pelvic radiograph with a pelvic binder;
- Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.
Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.
Measured: From enrollment to the end of primary injury evaluation at day 1
Young and Burgess classification
Each expert determines the Young and Burgess classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.
Measured: From enrollment to the end of primary injury evaluation at day 1
Pelvic ring mechanical stability assessment
Each expert determines the mechanical stability of the pelvic ring injury (pelvic ring fully stable, pelvic ring horizontally unstable, pelvic ring fully unstable) presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided assessments is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of mechanical stability assessment.
Measured: From enrollment to the end of primary injury evaluation at day 1
Surgical fixation plan
Each expert determines the surgical fixation plan (no fixation needed, anterior fixation only, posterior fixation only, lumboelvic fixation only, anterior and posterior fixation, anterior and lumbopelvic fixation) for the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided plans is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of surgical fixation planning.
Measured: From enrollment to the end of primary injury evaluation at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2012
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Ring InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Axel Gamulin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Axel Gamulin, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115602
- Sponsor's protocol ID
- VMOO_MDThesis_M_&_M
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified radiographic images of the pelvis (computed tomography scanners, standard anteroposterior radiographs with and without pelvic binder)
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multi-expert Diagnostic Imaging Evaluation of Pelvic Ring Injuries: Methodology for Transferring Large DICOM Data Volumes to Remote Experts, and Survey Designed to Isolate Information Obtained From Different Imaging Modalities
- ClinicalTrials.gov ID
- NCT07115602
- Acronym / sponsor ID
- VMOO_MDThesis_M_&_M
- Conditions
- Pelvic Ring Injury
- Keywords
- classification, assessment, computed tomography, stability, pelvic belt, pelvic ring injury, standard anteroposterior radiograph
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Axel GamulinUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 11 Aug 2025 (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 aim of this retrospective cohort study based on a prospectively filled registry was to determine whether standard anteroposterior pelvic radiographs with and without pelvic binder provide valuable information on pelvic ring injury anatomy and stability when compared to computed tomography images alone. The ultimate goal was to improve the management of these injuries in both emergency and definitive treatment.
Detailed description
At the core of the study was a stepwise pelvic imaging evaluation of pelvic ring injury patients by a panel of international pelvic trauma experts. The assessment was conducted in 3 sequential steps:
- Review of computed tomography images alone.
- Addition of a standard anteroposterior pelvic radiograph with a pelvic binder.
- Addition of a standard anteroposterior pelvic radiograph without a pelvic binder.
At each step, experts independently classified the injury (Arbeitsgemeinschaft für Osteosynthsesfragen / Orthopaedic Trauma Association and Young and Burgess classifications), assessed mechanical stability and recommended definitive treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic ring injury patients with operative management within 3 weeks from injury | – | –Pelvic ring injury patients with operative management within 3 weeks from injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult pelvic ring injury patients operatively treated within 3 weeks from injury
Key inclusion criteria (3 listed)
- 1) admission to the author's institution between January 2012 and December 2023;
- 2) high-energy pelvic ring injury involving a non-pathologic pelvis (i.e., no prior injury, pathology, or surgery compromising image interpretation), surgically treated within three weeks of injury;
- 3) age ≥18 years at the time of trauma.
Key exclusion criteria (4 listed)
- 1) imaging acquired after any kind of surgical stabilization (i.e. emergent external fixation), which could bias injury assessment;
- 2) incomplete imaging dataset, defined as the absence of any of the following: pelvic computed tomography, standard anteroposterior pelvic radiograph with pelvic binder, and standard anteroposterior pelvic radiograph without pelvic binder;
- 3) poor image quality, including incomplete pelvic coverage, computed tomography slice thickness >2 mm, motion artifacts, or incompatibility with the image viewer used for the study;
- 4) documented (written or verbal) refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification
Time frame: From enrollment to the end of primary injury evaluation at day 1
Each expert determines the AO/OTA classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1. Review of computed tomography images alone; 2. Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3. Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.
Young and Burgess classification
Time frame: From enrollment to the end of primary injury evaluation at day 1
Each expert determines the Young and Burgess classification of the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided classifications is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of injury classification.
Pelvic ring mechanical stability assessment
Time frame: From enrollment to the end of primary injury evaluation at day 1
Each expert determines the mechanical stability of the pelvic ring injury (pelvic ring fully stable, pelvic ring horizontally unstable, pelvic ring fully unstable) presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided assessments is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of mechanical stability assessment.
Surgical fixation plan
Time frame: From enrollment to the end of primary injury evaluation at day 1
Each expert determines the surgical fixation plan (no fixation needed, anterior fixation only, posterior fixation only, lumboelvic fixation only, anterior and posterior fixation, anterior and lumbopelvic fixation) for the pelvic ring injury presented by the patient (total = 28 pelvic ring injuries in 28 patients) following a 3 steps sequential imaging evaluation: 1) Review of computed tomography images alone; 2) Addition of a standard anteroposterior pelvic radiograph with a pelvic binder; 3) Addition of a standard anteroposterior pelvic radiograph without a pelvic binder. Each one of the 3 provided plans is recorded and compared to determine if standard anteroposterior pelvic radiographs (with and without a pelvic binder) add value to the information gained with computed tomography images alone in terms of surgical fixation planning.
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 11 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified radiographic images of the pelvis (computed tomography scanners, standard anteroposterior radiographs with and without pelvic binder)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Ring Injury, run by Axel Gamulin.
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 3 inclusion and 4 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Arbeitsgemeinschaft für Osteosynthesefragen / Orthopaedic Trauma Association (AO/OTA) classification (time frame: From enrollment to the end of primary injury evaluation at day 1). 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?
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 11 Aug 2025.