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Validating Osteoporosis Detection in Rho AI Software

Validating Osteoporosis Detection in Rho AI Software

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06830005
Enrollment
800
Registered
2025-02-17
Start date
2025-06-01
Completion date
2025-12-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia or Osteoporosis

Keywords

orthopedic surgery, screening

Brief summary

To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.

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.

Interventions

DEVICERho AI software

Rho is a AI enabled opportunistic pre-screening computer-aided detection and notification software for low bone mineral density.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* images from people who have undergone total joint arthroplasty * images from people who have undergone spine fusion

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
AI Predicted Osteoporosis Scorethrough 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026