NCT04041583 Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
| NCT ID | NCT04041583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Cervical Fusion |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2019-09-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Andrew Grossbach, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT04041583 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04041583 currently recruiting?
Yes, NCT04041583 is actively recruiting participants. Contact the research team at Aladdin.Alqaisi@osumc.edu for enrollment information.
Where is the NCT04041583 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT04041583 clinical trial?
NCT04041583 is sponsored by Ohio State University. The principal investigator is Andrew Grossbach, MD at Ohio State University. The trial plans to enroll 45 participants.