Investigation of DEXA-C Anterior Cervical Interbody System
ConditionDegenerative Disc Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAurora Spine and Pain
About this trial
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- DEXA-C Cervical Interbody System
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov