Vertebral FracturevertAIdoNCT07100756
Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice
An observational study of Vertebral Fracture and Osteoporosis, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate clinical effectiveness and cost-effectiveness after implementing a medically approved and commercially available AI support system for opportunistic vertebral fracture screening in CT examinations within an adapted fracture care pathway (integrated care process) in clinical… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Fracture, Osteoporosis
- What is being tested?
- AI vertebral fracture diagnostics (Flamingo)
- Type of treatment
- Medical device
- How many people
- 10,500 participants
- Where
- 1 siteSweden
- Study dates
- 20 Oct 2023to 19 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients >= 50 years, undergoing a clinical thoracic or abdominal CT-scan in at Linköping University Hospital
Who may be able to join
- abdominal or thoracic CT scans performed in clinical routine from patients living in the catchment area
- women and men
- age 50 or higher
Who cannot join
- -CT scans using spine-only protocol with exclusively skeletal queries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice - the vertAIdo Project (Vertebral Fracture AI Detection for Better Osteoporosis Care)
The aim of this study is to evaluate clinical effectiveness and cost-effectiveness after implementing a medically approved and commercially available AI support system for opportunistic vertebral fracture screening in CT examinations within an adapted fracture care pathway (integrated care process) in clinical routine. Data will be compared to historical data (same period the previous year).
The main question it aims to answer is: Does opportunistic AI-supported vertebral fracture screening in CT examinations integrated to a fracture care pathway increase the numbers of diagnosed vertebral fractures compared to usual care?
CT scans in the clinical routine care will be opportunistically screened for vertebral fractures by the AI for 4 months. All positive findings will be confirmed by a radiologist and triaged by the FLS (Fracture Liaison Service).
Read the detailed description
Objective: This study aims to compare a 4-month period during which AI support was integrated into the clinical fracture pathway (AI-cohort) with a historical cohort from the same period one year earlier (control-cohort). The prevalence of vertebral fractures on CT scans is expected to remain constant during this period.
The two cohorts include:
- The AI-cohort where an AI algorithm was installed and integrated into the clinical workflow to automatically analyze CT images of the thoracic or lumbar spine for vertebral fractures, i.e. opportunistic screening. The AI algorithm operates on local regional servers, ensuring that no images are sent externally. A worklist of positive findings, indicating the presence of vertebral fractures, is automatically generated in the radiology PACS (Picture Archiving and Communication System). This list is reviewed and verified by dedicated radiologists to confirm the AI findings. Confirmed fractures are then linked to the fracture liaison service (FLS), where the fracture coordinator and osteoporosis specialist care for further patient management according to clinical routine, i.e. based on a medical review, writes a referral to primary care, which will be responsible for further patient investigation and treatment of osteoporosis (i.e. usual care in the region).
- The control cohort (i.e. routine care), includes historical data from the same period the year before the AI-screening was introduced. In clinical routine, radiologists are expected to report incidental findings, such as vertebral fractures. The referring physician, who sends the referral to radiology, is then expected to act on the incidental finding of a vertebral fracture and is responsible for ensuring that the patient is managed further according to clinical routine for osteoporosis investigation and treatment.
Timeframe: Data from the AI-intervention period, spanning 4 months (20 October 2024-19 February 2025), will be analyzed. The same timeframe will be used for the historical cohort from the previous year (2023-2024).
- Conditions
- Vertebral Fracture, Osteoporosis
- Being tested
- AI vertebral fracture diagnostics (Flamingo)
- Keywords
- vertebral fracture, osteoporosis, computed tomography, AI
- Medical subject headings
- Spinal Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI vertebral fracture diagnostics (Flamingo)Device
The AI (name: Flamingo from Image Biopsy Lab, IBL, Vienna, Austria) screens thoracic and abdominal CT scans for vertebral fractures.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | The control cohort (usual care), representing routine care, consists of historical data from the corresponding period one year prior to the implementation of AI-based screening. In standard clinical practice, radiologists are expected to report incidental findings, including vertebral fractures. It is then the responsibility of the referring physician to act upon such findings and ensure appropriate follow-up. This includes initiating further investigation and treatment for osteoporosis in accordance with established clinical guidelines. | |
| AI screening aligned with FLS | In the AI cohort, an algorithm was integrated into the clinical workflow to automatically analyze CT scans of the thoracic and lumbar spine for vertebral fractures as part of opportunistic screening. Positive findings were automatically listed in the radiology PACS and subsequently reviewed and confirmed by dedicated radiologists. Confirmed fractures were referred to the Fracture Liaison Service (FLS), where a coordinator and osteoporosis specialist managed further care. Based on clinical assessment, a referral was issued to primary care, which remained responsible for continued investigation and treatment according to standard regional practice. Receives: Device: AI vertebral fracture diagnostics (Flamingo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral fractures (ICD coded)
Numbers of ICD-coded vertebral fractures within 3 months from the CT scan.
Measured: Within 3 months from CT scan
Secondary outcomes (4)
Reported vertebral fractures (radiology report)
Numbers of patients with vertebral fractures that are mentioned in the radiology report after the CT scan.
Measured: Within 2 months after the CT scan
DXA screened patients
Numbers of patients screened with DXA (osteoporosis investigation) within 1 year after the CT scan.
Measured: Within 12 months after the CT scan
Medical treatment (anti-osteoporotic)
Numbers of patients treated with antiosteoporotic drugs 1 year after CT scan.
Measured: Within 12 months after the CT scan
Cost-effectiveness
Incremental cost per outcome compared to no AI guidance.
Measured: Two time frames: Within 12 months after the CT scan and long-term using a decision-analytic model to assess outcome in 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start20 Oct 2023
- Primary completion19 May 2025
- Study completion19 Feb 2026 (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 Vertebral 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Spangeus, University Hospital, Linkoeping
- Investigators
- Anna Spångeus, Ass Prof MD, Principal investigator, Linköpings University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100756
- Sponsor's protocol ID
- vertAIdo
- Acronym
- vertAIdo
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woisetschlager M, Baldimtsi E, Lindblom M, Davidson T, Bjerner T, Spangeus A. Clinical implementation of AI for vertebral fracture detection in CT aligned with fracture liaison services: high prevalence of undiagnosed vertebral fractures. Osteoporos Int. 2026 Mar 10. doi: 10.1007/s00198-026-07907-9. Online ahead of print.
PubMed 41805842
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice - the vertAIdo Project (Vertebral Fracture AI Detection for Better Osteoporosis Care)
- ClinicalTrials.gov ID
- NCT07100756
- Acronym / sponsor ID
- vertAIdo / vertAIdo
- Conditions
- Vertebral Fracture, Osteoporosis
- Keywords
- vertebral fracture, osteoporosis, computed tomography, AI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,500 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 Feb 2026 (estimated)
- First posted
- 3 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 study is to evaluate clinical effectiveness and cost-effectiveness after implementing a medically approved and commercially available AI support system for opportunistic vertebral fracture screening in CT examinations within an adapted fracture care pathway (integrated care process) in clinical routine. Data will be compared to historical data (same period the previous year).
The main question it aims to answer is: Does opportunistic AI-supported vertebral fracture screening in CT examinations integrated to a fracture care pathway increase the numbers of diagnosed vertebral fractures compared to usual care?
CT scans in the clinical routine care will be opportunistically screened for vertebral fractures by the AI for 4 months. All positive findings will be confirmed by a radiologist and triaged by the FLS (Fracture Liaison Service).
Detailed description
Objective: This study aims to compare a 4-month period during which AI support was integrated into the clinical fracture pathway (AI-cohort) with a historical cohort from the same period one year earlier (control-cohort). The prevalence of vertebral fractures on CT scans is expected to remain constant during this period.
The two cohorts include:
- The AI-cohort where an AI algorithm was installed and integrated into the clinical workflow to automatically analyze CT images of the thoracic or lumbar spine for vertebral fractures, i.e. opportunistic screening. The AI algorithm operates on local regional servers, ensuring that no images are sent externally. A worklist of positive findings, indicating the presence of vertebral fractures, is automatically generated in the radiology PACS (Picture Archiving and Communication System). This list is reviewed and verified by dedicated radiologists to confirm the AI findings. Confirmed fractures are then linked to the fracture liaison service (FLS), where the fracture coordinator and osteoporosis specialist care for further patient management according to clinical routine, i.e. based on a medical review, writes a referral to primary care, which will be responsible for further patient investigation and treatment of osteoporosis (i.e. usual care in the region).
- The control cohort (i.e. routine care), includes historical data from the same period the year before the AI-screening was introduced. In clinical routine, radiologists are expected to report incidental findings, such as vertebral fractures. The referring physician, who sends the referral to radiology, is then expected to act on the incidental finding of a vertebral fracture and is responsible for ensuring that the patient is managed further according to clinical routine for osteoporosis investigation and treatment.
Timeframe: Data from the AI-intervention period, spanning 4 months (20 October 2024-19 February 2025), will be analyzed. The same timeframe will be used for the historical cohort from the previous year (2023-2024).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | – | –The control cohort (usual care), representing routine care, consists of historical data from the corresponding period one year prior to the implementation of AI-based screening. In standard clinical practice, radiologists are expected to report incidental findings, including vertebral fractures. It is then the responsibility of the referring physician to act upon such findings and ensure appropriate follow-up. This includes initiating further investigation and treatment for osteoporosis in accordance with established clinical guidelines. |
| AI screening aligned with FLS | – | Device: AI vertebral fracture diagnostics (Flamingo)In the AI cohort, an algorithm was integrated into the clinical workflow to automatically analyze CT scans of the thoracic and lumbar spine for vertebral fractures as part of opportunistic screening. Positive findings were automatically listed in the radiology PACS and subsequently reviewed and confirmed by dedicated radiologists. Confirmed fractures were referred to the Fracture Liaison Service (FLS), where a coordinator and osteoporosis specialist managed further care. Based on clinical assessment, a referral was issued to primary care, which remained responsible for continued investigation and treatment according to standard regional practice. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >= 50 years, undergoing a clinical thoracic or abdominal CT-scan in at Linköping University Hospital
Key inclusion criteria (3 listed)
- abdominal or thoracic CT scans performed in clinical routine from patients living in the catchment area
- women and men
- age 50 or higher
Key exclusion criteria (1 listed)
- -CT scans using spine-only protocol with exclusively skeletal queries
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 |
|---|---|---|
| AI vertebral fracture diagnostics (Flamingo)The AI (name: Flamingo from Image Biopsy Lab, IBL, Vienna, Austria) screens thoracic and abdominal CT scans for vertebral fractures. | Device | AI screening aligned with FLS |
Primary outcome
Vertebral fractures (ICD coded)
Time frame: Within 3 months from CT scan
Numbers of ICD-coded vertebral fractures within 3 months from the CT scan.
4 secondary outcomes
Reported vertebral fractures (radiology report)
Time frame: Within 2 months after the CT scan
DXA screened patients
Time frame: Within 12 months after the CT scan
Medical treatment (anti-osteoporotic)
Time frame: Within 12 months after the CT scan
Cost-effectiveness
Time frame: Two time frames: Within 12 months after the CT scan and long-term using a decision-analytic model to assess outcome in 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Derived from this study: PubMed 41805842Woisetschlager M, Baldimtsi E, Lindblom M, Davidson T, Bjerner T, Spangeus A. Clinical implementation of AI for vertebral fracture detection in CT aligned with fracture liaison services: high prevalence of undiagnosed vertebral fractures. Osteoporos Int. 2026 Mar 10. doi: 10.1007/s00198-026-07907-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Anna Spångeus, Ass Prof MD principal investigator
Linköpings University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Fracture and Osteoporosis, run by University Hospital, Linkoeping at 1 site in Sweden.
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 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vertebral fractures (ICD coded) (time frame: Within 3 months from CT scan). 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 NCT07100756, 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 3 Aug 2025.