Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alphatec Spine, Inc.
Study ID
NCT06659055
Status
Recruiting
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Conditions

  • Healthy
  • Indicated for EOSedge Imaging

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DXA Imaging — RADIATION
    DXA imaging: lumbar spine, bi-lateral femoral necks
  • EOSedge imaging — RADIATION
    Full body or full spine image

Study Details

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?

Key Dates

Start date
Sep 11, 2024
Status verified
Feb 2025
Primary completion
Feb 28, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
214 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Healthy Volunteers
    Healthy volunteers will undergo EOSedge and DXA imaging
  • Other: Subjects indicated for EOSedge imaging
    Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan.

Primary Outcome Measure

AP Spine T-score Agreement [ Time Frame: between 0-60 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Honor HealthPhoenixArizona85027
Lee (PRINCIPAL_INVESTIGATOR)
ATEC CarlsbadCarlsbadCalifornia92008-
ATEC MephisMemphisTennessee38118-
University of VirginiaCharlottesvilleVirginia22903
Lockey (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Honor Health· Phoenix, AZATEC Carlsbad· Carlsbad, CAATEC Mephis· Memphis, TNUniversity of Virginia· Charlottesville, VA

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