Clinical trial NCT06659055: Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA
Official title: Bone Mineral Density Assessment Using Dual-energy Stereoradiography: Agreement Between BMD T-scores From EOSedge™ Versus Traditional DXA - BMD Agreement Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Indicated for EOSedge Imaging
Lead sponsor: Alphatec Spine, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 214
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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?

Detailed 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.

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

Primary outcomes:
measure: AP Spine T-score Agreement
timeFrame: between 0-60 days
Secondary outcomes:
measure: Hip T-score Agreement
timeFrame: between 0-60 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Honor Health
state: Arizona
city: Carlsbad
country: United States
facility: ATEC Carlsbad
state: California
city: Memphis
country: United States
facility: ATEC Mephis
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: