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Recruiting NCT06659055

Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Trial Parameters

Condition Healthy
Sponsor Alphatec Spine, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 214
Sex ALL
Min Age 20 Years
Max Age N/A
Start Date 2024-09-11
Completion 2025-02
Interventions
DXA ImagingEOSedge imaging

Brief 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?

Eligibility Criteria

Inclusion Criteria: 1. Observational Arm: o Subjects at clinical sites, indicated for full-spine or whole-body radiography via EOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/or other orthopaedic conditions) as part of their routine medical care. Participants may already have completed their routine imagining, or may be scheduled to undergo it within 60 days of study enrollment. 2. Interventional Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study. 3. Male or female subjects who are at least 20 years of age at the time of imaging acquisition 4. Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study Exclusion Criteria: 1. Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA) 2. Subjects who are pregnant or wanting to become

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