Effectiveness of Implementation of Opportunistic AI-screening for Vertebral Fractures in Clinical Practice

NCT07100756 | Active Not Recruiting

• 1 other identifier: vertAIdo
• Study Type: observational
• Target: 10,500
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Vertebral Fracture; Osteoporosis

Keywords

vertebral fracture; osteoporosis; computed tomography; AI

Outcome Measures

Primary Outcomes (1)

• Vertebral fractures (ICD coded)

  Numbers of ICD-coded vertebral fractures within 3 months from the CT scan.

  Within 3 months from CT scan

Secondary Outcomes (4)

• Reported vertebral fractures (radiology report)

  Within 2 months after the CT scan

• DXA screened patients

  Within 12 months after the CT scan

• Medical treatment (anti-osteoporotic)

  Within 12 months after the CT scan

• Cost-effectiveness

  Two time frames: Within 12 months after the CT scan and long-term using a decision-analytic model to assess outcome in 10 years

Other Outcomes (6)

• Performance of AI

  Baseline

• Vertebral fractures (radiologist confirmed)

  Baseline

• New or worsened vertebral fractures

  Baseline

Study Arms (2)

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.

Device: AI vertebral fracture diagnostics (Flamingo)

Interventions

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.

AI screening aligned with FLS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients \>= 50 years, undergoing a clinical thoracic or abdominal CT-scan in at Linköping University Hospital

You may qualify if:

• abdominal or thoracic CT scans performed in clinical routine from patients living in the catchment area
• women and men
• age 50 or higher

You may not qualify if:

• CT scans using spine-only protocol with exclusively skeletal queries

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Linköping University Hospital

Linköping, Sweden

Location

MeSH Terms

Conditions

Spinal Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anna Spångeus, Ass Prof MD

  Linköpings University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof MD

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 3, 2025
• Study Start: October 20, 2023
• Primary Completion: May 19, 2025
• Study Completion: February 19, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)