Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Last updated: February 12, 2025
Sponsor: Alphatec Spine, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DXA Imaging

EOSedge imaging

Clinical Study ID

NCT06659055
ATEC.EOS-2402
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Observational Arm: o Subjects at clinical sites, indicated for full-spine or whole-body radiography viaEOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/orother orthopaedic conditions) as part of their routine medical care. Participantsmay already have completed their routine imagining, or may be scheduled to undergoit within 60 days of study enrollment.

  2. Interventional Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnosticimaging, as part of a research study.

  3. Male or female subjects who are at least 20 years of age at the time of imagingacquisition

  4. Written informed consent obtained from the potential subject and ability for thesubject to comply with the requirements of the study

Exclusion

Exclusion Criteria:

  1. Subjects who have been administered contrast agents or radionuclides within 7 daysprior to scheduled radiographic imaging (EOS and DXA)

  2. Subjects who are pregnant or wanting to become pregnant during the timeframe ofstudy 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 themeasurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; notethat unilateral femoral evaluation is acceptable), as defined by the Investigator'sdetermination of the likelihood of reasonably assessing bone mineral density ofthose areas

  5. Subjects known to have implants, hardware, devices, or other foreign material in themeasurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; notethat unilateral femoral evaluation is acceptable)

  6. Subjects unable to attain correct position and/or remain motionless for themeasurement (e.g., subjects unable to stand unassisted in the EOS unit, or to lieappropriately in the DXA scanner)

  7. Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5mobile lumbar segments)

  8. Subjects participating in another clinical study which may compromise this study'sresults or compliance with this study's procedures

  9. Subjects with presence of a condition or abnormality that in the opinion of theInvestigator would compromise the safety of the subject or the quality of the data

Study Design

Total Participants: 214
Treatment Group(s): 2
Primary Treatment: DXA Imaging
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
March 31, 2025

Study Description

This is a multi-center, prospective, controlled, cross-sectional agreement study of subjects indicated for radiography using EOSedge biplanar full-body or full-spine imaging OR volunteers undergoing non-diagnostic imaging.

From the potential pool of EOSedge examinees, screening data will be reviewed to determine further eligibility. Subjects who sign an informed consent form and meet all inclusion criteria and none of the exclusion criteria will be asked to participate in the study.

Subjects who consent to participate will be enrolled from the time of consent through completion of evaluable image acquisition which will include both EOSedge and DXA scans.

EOSedge exams will be performed as is typical for the evaluation of spinal and/or other orthopaedic conditions, and the output will be collected for post-hoc computation of BMD.

DXA exams will be study-prescribed (or standard of care if consistent with this protocol) and ideally performed on the same day as EOSedge exams (but may be scheduled as much as 60 days apart).

In addition to the radiographic imaging from which spinal/postural alignment parameters may be obtained, some demographic and diagnostic details about the subject will be captured via study-specific case report forms (CRFs). Subjects will also complete a questionnaire that every subject fills out prior to having a DXA scan according to ISCD guidance.

Connect with a study center

  • Honor Health

    Phoenix, Arizona 85027
    United States

    Active - Recruiting

  • ATEC Carlsbad

    Carlsbad, California 92008
    United States

    Site Not Available

  • ATEC Mephis

    Memphis, Tennessee 38118
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.