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Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Cervical Interfacet Spacers (device)
Sponsor: Ohio State University · Participants: 45 · Started: Sep 1, 2019
Contact the study team
- Aladdin A Alqaisi, MPH · Phone: 614-814-7007
- Allie Garvin, BS · Phone: 614-688-8304
Official record on ClinicalTrials.gov — NCT04041583
Locations in the U.S.
| Ohio | The Ohio State University Wexner Medical Center, Columbus |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.