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

NCT ID: NCT07100756

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 10500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2026-02-19

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).

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:

1. 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).

2. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

AI vertebral fracture diagnostics (Flamingo)

Intervention Type: DEVICE

The AI (name: Flamingo from Image Biopsy Lab, IBL, Vienna, Austria) screens thoracic and abdominal CT scans for vertebral fractures.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Anna Spangeus

Assoc Prof MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Spångeus, Ass Prof MD

Role: PRINCIPAL_INVESTIGATOR

Linköpings University Hospital

Locations

Linköping University Hospital

Linköping, , Sweden

Countries

Sweden

Other Identifiers

vertAIdo

Identifier Type: -

Identifier Source: org_study_id