Investigation of a new cervical interbody system for spine fusion
A Prospective, Multi-Center Investigation of the DEXA- C Anterior Cervical Interbody System
This study is testing a new spinal implant designed to help patients with degenerative disc disease and nerve pain recover better from surgery by improving the fusion of their spine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aurora Spine and Pain Industry-sponsored |
| Locations | 4 sites (Orange, California and 3 other locations) |
| Trial ID | NCT05883436 on ClinicalTrials.gov |
What this trial studies
The DEXA-C Cervical Interbody System is designed for anterior cervical interbody fusion in patients with degenerative disc disease and radicular symptoms. This interbody product is tailored to match a patient's DEXA scan to potentially enhance fusion rates. The study will collect data on patients treated with this system to better understand its outcomes and effectiveness. It involves the use of supplemental fixation and bone grafting to facilitate the fusion process.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature patients scheduled for anterior cervical discectomy and fusion due to degenerative disc disease with radicular symptoms.
Not a fit: Patients with a history of cervical spine surgery within the last 12 months or those requiring posterior cervical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved fusion rates and better outcomes for patients undergoing cervical spine surgery.
How similar studies have performed: Other studies have shown promise with similar interbody fusion approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution). 3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy. 4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms. 5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication). Exclusion Criteria: 1. History of cervical spine surgery less than 12 months prior to surgery. 2. Diagnosis of severe spondylosis. 3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery. 4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)
Where this trial is running
Orange, California and 3 other locations
- UCI Center for Clinical Research — Orange, California, United States (Recruiting)
- Orthopaedic Institute of Western KY — Paducah, Kentucky, United States (Recruiting)
- Koga Neurosurgery — Covington, Louisiana, United States (Recruiting)
- Optima Orthopedics — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Martineck, PA
- Email: smartineck@auroraspine.us
- Phone: 716-870-7535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.