Investigation of DEXA-C Anterior Cervical Interbody System
A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
Aurora Spine and Pain
80 participants
Feb 22, 2023
INTERVENTIONAL
Conditions
Summary
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
Eligibility
Inclusion Criteria5
- 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.
- At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).
Exclusion Criteria4
- 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.)
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Interventions
The Dexa-C Cervical Interbody System is intended for use on patients who require anterior cervical discectomy and fusion surgery. The system implants an interbody spacer(s) into the cervical intervertebral body space(s) to stabilize and fuse the level(s). Allograft will be used in the spacer and the spinal segment(s) are fixed with an anterior cervical plate
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05883436