Bone Mineral Density Precision Study

Recruiting now · Not applicable

Conditions studied: Indicated for EOSedge Imaging

In brief

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?

Key facts

Study ID

NCT06830811

Run by

Alphatec Spine, Inc.

People needed

30

Starts

2024-11-13

Expected to finish

2025-03-01

Last updated by the study team

2025-02-17

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Male or female subjects who are at least 20 years of age at the time of imaging acquisition
• 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

You may not qualify if…

• Subjects who have been administered contrast agents or radionuclides within 7 days prior to scheduled radiographic imaging (EOS and DXA)
• Subjects who are pregnant or wanting to become pregnant during the timeframe of study participation (due to risks associated with radiographic imaging)
• Subjects with a BMI ≥ 35 kg/m2
• 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
• 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)
• 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)
• Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5 mobile lumbar segments)
• Subjects participating in another clinical study which may compromise this study's results or compliance with this study's procedures
• 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

Where it is running

• OrthoIndy — Fishers, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.