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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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).

Locations
United States
California
UCI Center for Clinical Research
RECRUITING
Orange
Kentucky
Orthopaedic Institute of Western KY
RECRUITING
Paducah
Louisiana
Koga Neurosurgery
RECRUITING
Covington
Oklahoma
Optima Orthopedics
RECRUITING
Oklahoma City
Contact Information
Primary
Sarah Martineck, PA
smartineck@auroraspine.us
716-870-7535
Backup
Matthew Goldstone
mgoldstone@auroraspine.us
626-664-3364
Time Frame
Start Date: 2023-02-22
Estimated Completion Date: 2027-02-22
Participants
Target number of participants: 80
Treatments
Other: Single Arm Observational
Cervical Interbody Cage
Related Therapeutic Areas
Sponsors
Leads: Aurora Spine and Pain

This content was sourced from clinicaltrials.gov

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