Investigation of DEXA-C Anterior Cervical Interbody System

Description

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

Conditions

Degenerative Disc Disease

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Study Overview

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Study Details

Study overview

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

A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System

Investigation of DEXA-C Anterior Cervical Interbody System

Condition
Degenerative Disc Disease
Intervention / Treatment

-

Contacts and Locations

Orange

UCI Center for Clinical Research, Orange, California, United States, 92868

Paducah

Orthopaedic Institute of Western KY, Paducah, Kentucky, United States, 42003

Covington

Koga Neurosurgery, Covington, Louisiana, United States, 70433

Bryn Mawr

Center for Interventional Pain & Spine, Bryn Mawr, Pennsylvania, United States, 19010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Aurora Spine and Pain,

Study Record Dates

2025-12-31