Investigation of DEXA-C Anterior Cervical Interbody System

Part of paid clinical trials in Orange, California.

Sponsor
Aurora Spine and Pain
Study ID
NCT05883436
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DEXA-C Cervical Interbody System — DEVICE
    The Dexa-C Cervical Interbody System is intended for use on patients who require anterior cervical discectomy and fusion surgery. The system implants an interbody spacer(s) into the cervical intervertebral body space(s) to stabilize and fuse the level(s). Allograft will be used in the spacer and the spinal segment(s) are fixed with an anterior cervical plate

Study Details

FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.

Key Dates

Start date
Feb 22, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Feb 22, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Single Arm Observational
    Cervical Interbody Cage

Primary Outcome Measure

Fusion Assesment [ Time Frame: 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCI Center for Clinical ResearchOrangeCalifornia92868
Amanda Thorton
[email protected]
(714)-456-7539
Sohaib Hashmi, MD (PRINCIPAL_INVESTIGATOR)
Kiarash Golshani, MD (SUB_INVESTIGATOR)
Yu-Po Lee, MD (SUB_INVESTIGATOR)
Hao-Hua Wu, MD (SUB_INVESTIGATOR)
Michael Oh, MD (SUB_INVESTIGATOR)
Orthopaedic Institute of Western KYPaducahKentucky42003
Rebecca Vinson
[email protected]
(270) 228-3973
Kenneth B Strenge, MD (PRINCIPAL_INVESTIGATOR)
Koga NeurosurgeryCovingtonLouisiana70433
Hannah Boren
[email protected]
985-777-5642
Sebastian Koga, MD (PRINCIPAL_INVESTIGATOR)
Optima OrthopedicsOklahoma CityOklahoma73159
Amee Stapleton
[email protected]
888-957-7463
Jeffrey Moore, MB (PRINCIPAL_INVESTIGATOR)
Kate McLellan (SUB_INVESTIGATOR)

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By research site
UCI Center for Clinical Research· Orange, CAOrthopaedic Institute of Western KY· Paducah, KYKoga Neurosurgery· Covington, LAOptima Orthopedics· Oklahoma City, OK

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