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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

DEXA-C Cervical Interbody System
Device
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

Treatment groups

80 Participants

are divided into 1 treatment group

Group A: Single Arm ObservationalOther 1 intervention

Trial outcomes

Primary outcomes

Fusion Assesment

The primary outcomes of interest for this study will be fusion assessment at 3 months, 6 months and 12 months post-surgery. Fusion assessment from Static and Dynamic X-Ray (AP/LAT/Flex/Ex) using the following criteria: Bridging bone inside or outside of graft No lucencies at the graft-vertebral body junction Motion \< 1mm

Time frame

12 months

Secondary outcomes

Subsidence

Secondary outcome measures will include subsidence. Patient reported outcomes (Neck Disability Index on a 0-50 scale (NDI) and Visual Analog Scale for Pain (VAS) on a 0-10 scale will be collected at follow up visits and assessed compared to baseline.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aurora Spine and Pain

Lead sponsor

Source ClinicalTrials.gov

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