Investigation of DEXA-C Anterior Cervical Interbody System

NCT05883436 | Recruiting FDA Device

• 1 other identifier: 01-AUR-DEXA-23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Degenerative Disc Disease

Keywords

fusion; subsidence

Outcome Measures

Primary Outcomes (1)

• Fusion Assesment

  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

  12 months

Secondary Outcomes (1)

• Subsidence

  12 months

Study Arms (1)

Single Arm Observational

OTHER

Cervical Interbody Cage

Device: DEXA-C Cervical Interbody System

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

Single Arm Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
• Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
• Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
• At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).

You may not qualify if:

• History of cervical spine surgery less than 12 months prior to surgery.
• Diagnosis of severe spondylosis.
• Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
• Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

Sponsors & Collaborators

• Aurora Spine and Pain: lead

Study Sites (4)

UCI Center for Clinical Research

Orange, California, 92868, United States

RECRUITING

Orthopaedic Institute of Western KY

Paducah, Kentucky, 42003, United States

RECRUITING

Koga Neurosurgery

Covington, Louisiana, 70433, United States

RECRUITING

Optima Orthopedics

Oklahoma City, Oklahoma, 73159, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Sarah Martineck, PA

CONTACT

716-870-7535; smartineck@auroraspine.us

Matthew Goldstone

CONTACT

626-664-3364; mgoldstone@auroraspine.us

Study Design

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

Model Details: The Dexa-C Study will be conducted at up to 10 investigative sites in the United States. It is anticipated that at least 40 single level subjects and at least 40 multiple level subjects will be enrolled into the Study.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: June 1, 2023
• Study Start: February 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 22, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)