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Active, not recruiting Not applicable

Investigation of DEXA-C Anterior Cervical Interbody System

NCT05883436 · tracked via the Priya Life Science USA tracker
Sponsor
Aurora Spine and Pain
Phase
Not applicable
Started
2023-02-22
Last updated
2026-08-24

Condition(s) studied

Degenerative Disc Disease

Investigational drug(s) / intervention(s)

DEXA-C Cervical Interbody System

DEXA-C Cervical Interbody System: 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 summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria. 2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution). 3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy. 4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms. 5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication). Exclusion Criteria: 1. History of cervical spine surgery less than 12 months prior to surgery. 2. Diagnosis of severe spondylosis. 3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery. 4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

Primary outcome measure(s)

  • Fusion Assesment — 12 months
    The primary outcomes of interest for this study will be fusion assessment at 3 months, 6 months and 12 months post-surgery. Fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria: Bridging bone inside or outside of graft No lucencies at the graft-vertebral body junction Motion \< 1mm

Trial sites (4)

FacilityCityRegionStatus
UCI Center for Clinical Research Orange California
Orthopaedic Institute of Western KY Paducah Kentucky
Koga Neurosurgery Covington Louisiana
Optima Orthopedics Oklahoma City Oklahoma
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05883436 on ClinicalTrials.gov ↗ ← All trials in the USA