Status:
COMPLETED
Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Medtronic
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
This study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients h...
Detailed Description
This is a prospective single arm study of clinical and radiological outcomes as well as surgical data from posterior cervical fusion for treating degenerative disc disease (DDD). Patients undergoing p...
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)
- Clinically diagnosed osteoporosis
- 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
- Other contraindications for Medtronic Infinity System
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04056520
Start Date
September 1 2019
End Date
December 13 2024
Last Update
March 21 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210