Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT04041583
- Status
- Recruiting
Conditions
- Cervical Fusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cervical Interfacet Spacers — DEVICEThe use of Cervical Interfacet Spacers is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis \[2\]. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion \[2\].
Study Details
This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.
Key Dates
- Start date
- Sep 1, 2019
- Status verified
- Dec 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 45 participants (estimated)
Arms
- Arm: Arm 1Patients undergoing posterior cervical arthrodesis procedures for spondylosis supplemented with CIS involving three or more segmental levels in the subaxial cervicothoracic spine (between C2-upper thoracic)
Primary Outcome Measure
Cervical Fusion [ Time Frame: 2-Years ]
Central Contacts
- Aladdin A Alqaisi, MPH614-814-7007
- Allie Garvin, BS614-688-8304
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | Andrew Grossbach, MD (PRINCIPAL_INVESTIGATOR) |
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