NCT06659055

Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Alphatec Spine, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two different types of low-dose x-ray exams, EOSedge and conventional DXA. The main question it aims to answer is: Is there agreement between the calculated T-scores between the 2 different types of x-ray exams?

Detailed description

This is a multi-center, prospective, controlled, cross-sectional agreement study of subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging OR volunteers undergoing non-diagnostic imaging. From the potential pool of EOSedge examinees, screening data will be reviewed to determine further eligibility. Subjects who sign an informed consent form and meet all inclusion criteria and none of the exclusion criteria will be asked to participate in the study. Subjects who consent to participate will be enrolled from the time of consent through completion of evaluable image acquisition which will include both EOSedge and DXA scans. EOSedge exams will be performed as is typical for the evaluation of spinal and/or other orthopaedic conditions, and the output will be collected for post-hoc computation of BMD. DXA exams will be study-prescribed (or standard of care if consistent with this protocol) and ideally performed on the same day as EOSedge exams (but may be scheduled as much as 60 days apart). In addition to the radiographic imaging from which spinal/postural alignment parameters may be obtained, some demographic and diagnostic details about the subject will be captured via study-specific case report forms (CRFs). Subjects will also complete a questionnaire that every subject fills out prior to having a DXA scan according to ISCD guidance.

Conditions

• Healthy
• Indicated for EOSedge Imaging

Interventions

Type	Name	Description
RADIATION	DXA Imaging	DXA imaging: lumbar spine, bi-lateral femoral necks
RADIATION	EOSedge imaging	Full body or full spine image

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2024-10-26
• Last updated: 2025-02-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study