Comparing bone density measurements from EOSedge and traditional DXA imaging

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

This study is testing if a new imaging method called EOSedge gives similar bone density results as the traditional DXA scan for people needing these tests.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Alphatec Spine, Inc. (industry)
• Locations: 4 sites (Phoenix, Arizona and 3 other locations)
• Trial ID: NCT06659055 on ClinicalTrials.gov

What this trial studies

This research aims to compare bone mineral density (BMD) measurements obtained from two different imaging techniques: EOSedge and conventional DXA. It is a multi-center, prospective, controlled study involving subjects indicated for EOSedge imaging or volunteers undergoing non-diagnostic imaging. Participants will undergo both EOSedge and DXA scans, with data collected to assess the agreement between the T-scores derived from each method. The study will also gather demographic and diagnostic information through questionnaires and case report forms.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 20 and older who are indicated for full-spine or whole-body radiography using EOSedge imaging.

Not a fit: Patients who have received contrast agents or radionuclides within the past week or who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and less invasive method for assessing bone mineral density in patients.

How similar studies have performed: While the comparison of imaging techniques is common, this specific approach using EOSedge versus DXA is relatively novel and has not been extensively tested.

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 pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
3. Subjects with a BMI ≥ 35 kg/m2
4. 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
5. 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)
6. 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)
7. Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
8. Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
9. 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

Where this trial is running

Phoenix, Arizona and 3 other locations

• Honor Health — Phoenix, Arizona, United States (RECRUITING)
• ATEC Carlsbad — Carlsbad, California, United States (ACTIVE_NOT_RECRUITING)
• ATEC Mephis — Memphis, Tennessee, United States (ACTIVE_NOT_RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Sr. Manager, Clinical Studies

Conditions: Healthy, Indicated for EOSedge Imaging