Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

NCT06659055 | Recruiting FDA Device

• 1 other identifier: ATEC.EOS-2402
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 4

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?

Conditions

Healthy; Indicated for EOSedge Imaging

Outcome Measures

Primary Outcomes (1)

• AP Spine T-score Agreement

  Calculation of EOSedge BMD will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. BMD results from the conventional DXA system will be similarly acquired from the spine (AP L1-L4) exam, and the paired T-scores derived from the BMD results will be tested for statistical agreement across the two systems.

  between 0-60 days

Secondary Outcomes (1)

• Hip T-score Agreement

  between 0-60 days

Study Arms (2)

Healthy Volunteers

OTHER

Healthy volunteers will undergo EOSedge and DXA imaging

Radiation: DXA Imaging; Radiation: EOSedge imaging

Subjects indicated for EOSedge imaging

OTHER

Subject receiving EOSedge imaging as SOC will also receive an additional DXA scan.

Radiation: DXA Imaging

Interventions

DXA Imaging RADIATION

DXA imaging: lumbar spine, bi-lateral femoral necks

Healthy Volunteers; Subjects indicated for EOSedge imaging

EOSedge imaging RADIATION

Full body or full spine image

Healthy Volunteers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Interventional Arm:
• o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnostic imaging, as part of a research study.
• Male or female subjects who are at least 20 years of age at the time of imaging acquisition
• Written informed consent obtained from the potential subject and ability for the subject to comply with the requirements of the study

You may not qualify if:

• Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
• Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
• Subjects with a BMI ≥ 35 kg/m2
• Subjects known to have severe degenerative changes or fracture deformity in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable), as defined by the Investigator's determination of the likelihood of reasonably assessing bone mineral density of those areas
• Subjects known to have implants, hardware, devices, or other foreign material in the measurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; note that unilateral femoral evaluation is acceptable)
• Subjects unable to attain correct position and/or remain motionless for the measurement (e.g., subjects unable to stand unassisted in the EOS unit, or to lie appropriately in the DXA scanner)
• Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
• Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
• Subjects with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (4)

Honor Health

Phoenix, Arizona, 85027, United States

RECRUITING

ATEC Carlsbad

Carlsbad, California, 92008, United States

ACTIVE NOT RECRUITING

ATEC Mephis

Memphis, Tennessee, 38118, United States

ACTIVE NOT RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Central Study Contacts

Sr. Manager, Clinical Studies

CONTACT

858-603-3139; vshainsky@atecspine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: September 11, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (4)