Assessing outcomes of cervical fusion with interfacet spacers
Official title: Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Run by Ohio State University · NCT04041583 · Data updated 2026-11-12
This study is testing how well a new type of spacer works in helping patients recover from neck surgery and if it can prevent complications like nerve problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | September 1, 2019 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT04041583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with symptomatic multi-level degenerative spondylosis requiring posterior cervical arthrodesis.
✕Probably not a fit
Patients with traumatic injuries, severe co-morbidities, or those on medications that interfere with healing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study evaluates fusion rates and cervical sagittal parameters in patients undergoing posterior cervical arthrodesis supplemented with interfacet spacers. Data will be collected from medical records for up to 730 days post-surgery, including demographic, clinical, surgical, and radiographic information. Additionally, patients will receive a non-standard CT scan two years after their surgery to assess long-term outcomes. The study aims to address complications associated with cervical fusion, such as foraminal stenosis and C5 palsy.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and reduce complications for patients undergoing cervical fusion.
How similar studies have gone: While the use of interfacet spacers is a novel approach in this context, similar studies have shown promising results in improving foraminal height and reducing complications.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old * Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic). * Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC) Exclusion Criteria: * Traumatic injury * Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator * Severe co-morbidities (e.g., heart, respiratory, or renal disease) * Recent (\<3 yrs) or co-incident spinal tumor or infection * Concurrent involvement in another investigational drug or device study that could confound study data * History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up * Subjects who are pregnant or plan to become pregnant in the next 24 months * Prisoner
Where it's running
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Andrew Grossbach, MD — Ohio State University
- Study coordinator: Aladdin A Alqaisi, MPH
- Email: Aladdin.Alqaisi@osumc.edu
- Phone: 614-814-7007
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.