Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Description

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

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Study Overview

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Study Details

Study overview

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?

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

Bone Mineral Density Agreement Study Between EOSedge™ Versus Traditional DXA

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Carlsbad

ATEC Carlsbad, Carlsbad, California, United States, 92008

Memphis

ATEC Mephis, Memphis, Tennessee, United States, 38118

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Observational Arm:
  • 2. Interventional Arm:
  • 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
  • 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

Ages Eligible for Study

20 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Alphatec Spine, Inc.,

Study Record Dates

2025-03