Bone Mineral Density Precision Study

NCT06830811 | Recruiting FDA Device

• 1 other identifier: ATEC.EOS-2403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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?

Conditions

Indicated for EOSedge Imaging

Outcome Measures

Primary Outcomes (1)

• AP Spine BMD Precision

  Calculation of EOSedge BMD from the 2 exams will be post-processed from the bi-planar EOSedge 2E radiographs, and is measured in g/cm² surface mass on four lumbar vertebrae (L1-L4) in the anteroposterior (AP) projection. Precision error will be calculated from the 2 exams.

  1 day

Secondary Outcomes (2)

• Hip BMD Precision

  1 day

• Lateral L2-L3 Precision

  1 day

Study Arms (1)

Subjects indicated for EOSedge imaging

OTHER

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

Radiation: EOSedge imaging

Interventions

EOSedge imaging RADIATION

Full body or full spine image

Subjects indicated for EOSedge imaging

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (1)

OrthoIndy

Fishers, Indiana, 46038, United States

RECRUITING

Central Study Contacts

Sr. Manager, Clinical Studies

CONTACT

858-603-3139; vshainsky@atecspine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: November 13, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)