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Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers

Recruitingn/aAges 18 Years - anyAllOhio State University
NCT04041583 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Cervical Interfacet Spacers
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Where

1 site
The Ohio State University Wexner Medical Center
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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