Investigation of DEXA-C Anterior Cervical Interbody System

Last updated: January 27, 2025
Sponsor: Aurora Spine and Pain
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DEXA-C Cervical Interbody System

Clinical Study ID

NCT05883436
01-AUR-DEXA-23
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must already be scheduled or planned for anterior cervical discectomy and fusionusing the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/orallogenic bone graft composed of cancellous, cortical, and/or cortico-cancellousbone meeting on-label criteria.

  2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresisin a specific nerve root distribution).

  3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7requiring open anterior cervical fusion and discectomy.

  4. Diagnosis of degenerative disc disease by radiographic evidence of cervical discherniation and/or osteophytes accompanying clinical symptoms.

  5. At least 6 weeks prior conservative treatment (i.e. physical therapy, painmedication).

Exclusion

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, orrevision surgery.

  4. Any member of a vulnerable population (ie. minors, adults who lack the ability toconsent, pregnant women, etc.)

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: DEXA-C Cervical Interbody System
Phase:
Study Start date:
February 22, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. Device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better understanding of outcomes associated with it.

Connect with a study center

  • UCI Center for Clinical Research

    Orange, California 92868
    United States

    Active - Recruiting

  • Orthopaedic Institute of Western KY

    Metropolis, Illinois 62960
    United States

    Site Not Available

  • Orthopaedic Institute of Western KY

    Paducah, Kentucky 42003
    United States

    Active - Recruiting

  • Koga Neurosurgery

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Optima Orthopedics

    Oklahoma City, Oklahoma 73159
    United States

    Active - Recruiting

  • Center for Interventional Pain & Spine

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

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