Recruiting

EOSedge™ vs. DXA

Sponsor:

Alphatec Spine, Inc.

Code:

NCT06659055

Conditions

Healthy

Indicated for EOSedge Imaging

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

DXA Imaging

EOSedge imaging

Study Details

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

Study ID

NCT06659055

Start date

Sep 11, 2024

Status verified date

Feb, 2025

Completion date

Mar, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

214 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

DXA Imaging

DXA imaging: lumbar spine, bi-lateral femoral necks

EOSedge imaging

Full body or full spine image

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sr. Manager, Clinical Studies

858-603-3139vshainsky@atecspine.com

Locations

Honor Health

Recruiting

Phoenix, Arizona, United States, 85027

Principal Investigator:

Lee

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Lockey

More Information

Sponsor

Alphatec Spine, Inc.

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alphatec Spine, Inc. on 2025-02-14.