RecruitingNot Applicable

Investigation of DEXA-C Anterior Cervical Interbody System

United States80 participantsStarted 2023-02-22

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.)

Fusion Assesment

Timeframe: 12 months

NCT IDNCT05883436

SponsorAurora Spine and Pain

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Sarah Martineck, PA