X-ray for Bone Density

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Alphatec Spine, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research is to collect medical imaging data to allow for the comparison of bone mineral density measurements from two low-dose x-ray exams. The main question it aims to answer is: What is the precision measurement between the BMD assessments from 2 x-ray exams?

Eligibility Criteria

This trial is for adults at least 20 years old needing full-spine or whole-body x-ray exams with EOSedge imaging. Participants must be able to stand still for the exam and not be pregnant, have implants in the measurement area, severe spine deformities, a BMI over 35, recent contrast agents use, or an abnormal number of lumbar vertebrae.

Inclusion Criteria

Subjects 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)

Written informed consent obtained from the potential subject or the subject's legal representative and ability for the subject to comply with the requirements of the study

I am 20 years old or older.

Exclusion Criteria

Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)

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)

I can stand or lie still for scans without help.

See 6 more

Treatment Details

Interventions

EOSedge imaging (Other)

Trial OverviewThe study tests the precision of bone mineral density measurements between two low-dose x-ray exams using EOSedge imaging technology. It aims to determine how consistent BMD assessments are when taken from different x-rays.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Subjects indicated for EOSedge imagingExperimental Treatment1 Intervention

Subject receiving EOSedge imaging as SOC will also receive an additional EOSedge scan.