Bone Mineral Density Precision Study

Precision Assessment of Bone Mineral Density (BMD) Measurement with EOSedge™ - BMD Precision Study

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?

Study Overview

• Status: Recruiting
• Conditions: Indicated for EOSedge Imaging
• Intervention / Treatment: Radiation: EOSedge imaging

Detailed Description

This is a single-center, prospective, precision study of 30 subjects indicated for radiography using EOSedge biplanar full-body or full-spine 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 exams.

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.

The second EOS exam will be study prescribed and performed immediately after the first exam, with the operator repositioning the subject between acquisitions, i.e., removing the subject from the scanner and repositioning between exams.

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 bone mineral density scan according to ISCD guidance.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sr. Manager, Clinical Studies; Phone Number: 858-603-3139; Email: vshainsky@atecspine.com

Study Locations

• United States
  • Indiana
    • Fishers, Indiana, United States, 46038
      • Recruiting
      • OrthoIndy
      • Contact: Schwartz
      • Contact: McMains

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. Male or female subjects who are at least 20 years of age at the time of imaging acquisition
3. 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects indicated for EOSedge imaging; Subject receiving EOSedge imaging as SOC will also receive an additional EOSedge scan.	Radiation: EOSedge imaging; Full body or full spine image

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip 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 at the hip (femoral necks). Precision error will be calculated from the 2 exams.	1 day
Lateral L2-L3 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 at the spine (lateral L2-L3). Precision error will be calculated from the 2 exams.	1 day

Collaborators and Investigators

• Sponsor: Alphatec Spine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ATEC.EOS-2403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No