Status:
RECRUITING
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Medtronic
Conditions:
Cervical Fusion
Eligibility:
All Genders
18+ years
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 recor...
Detailed Description
Background and Rationale Posterior cervical fusion surgeries are performed for degenerative cervical conditions, cervical deformity, cervical tumors, and cervical trauma. They are preferred over an a...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04041583
Start Date
September 1 2019
End Date
August 1 2026
Last Update
December 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210