Validating Osteoporosis Detection in Rho AI Software
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoporosis is underrecognized and undertreated in the orthopedic surgery patient population. Osteoporosis is diagnosed by dual-energy x-ray absorptiometry which is costly and imparts radiation. Preoperative radiographs are universally obtained in orthopedic surgery patients, however up to this point radiographs have not been able to diagnose osteoporosis. This software program is a new technology that is able to leverage radiographs to opportunistically screen for osteoporosis.
The study team will identify applicable patient records from medical record review, and Radius will de-identify the x-ray images. The de-identified images will be run through the Rho AI program to identify osteoporosis or osteopenia, and a report will be generated to summarize the program's findings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- UW School of Medicine and Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- images from people who have undergone total joint arthroplasty
- images from people who have undergone spine fusion
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Detection of Osteoporosis
|
Rho is a AI enabled opportunistic pre-screening computer-aided detection and notification software for low bone mineral density.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AI Predicted Osteoporosis Score
Time Frame: through study completion (data collected up to 1 month)
|
Osteoporosis score is a T-score where -1.0 and above: Normal bone density, -1.0 to -2.5: Osteopenia (low bone mass), -2.5 and below: Osteoporosis
|
through study completion (data collected up to 1 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bernatz, MD, UW School of Medicine and Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-1832
- Protocol Version (Other Identifier: UW Madison)
- A536100 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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