Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Nitin Bhatia, MD

Description

Summary

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

Official Title

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

Details

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.

Keywords

Degenerative Disc Disease, fusion, subsidence, Intervertebral Disc Degeneration, DEXA-C Cervical Interbody System

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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.)

Locations

  • UCI Center for Clinical Research not yet accepting patients
    Orange California 92868 United States
  • Orthopaedic Institute of Western KY accepting new patients
    Metropolis Illinois 62960 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Aurora Spine and Pain
ID
NCT05883436
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated