RECRUITING

Investigation of DEXA-C Anterior Cervical Interbody System

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Conditions

Degenerative Disc Diseasefusionsubsidence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-02-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05883436

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
  3. 3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
  4. 4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
  5. 5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).
  1. 1. History of cervical spine surgery less than 12 months prior to surgery.
  2. 2. Diagnosis of severe spondylosis.
  3. 3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
  4. 4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

Contacts and Locations

Study Contact

Sarah Martineck, PA
CONTACT
716-870-7535
smartineck@auroraspine.us
Matthew Goldstone
CONTACT
626-664-3364
mgoldstone@auroraspine.us

Study Locations (Sites)

UCI Center for Clinical Research
Orange, California, 92868
United States
Orthopaedic Institute of Western KY
Paducah, Kentucky, 42003
United States
Koga Neurosurgery
Covington, Louisiana, 70433
United States
Center for Interventional Pain & Spine
Bryn Mawr, Pennsylvania, 19010
United States

Collaborators and Investigators

Sponsor: Aurora Spine and Pain

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-02-22
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • fusion
  • subsidence

Additional Relevant MeSH Terms

  • Degenerative Disc Disease