Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
ConditionCervical Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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
Qualifiers
≥ 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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cervical Interfacet Spacers
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Ohio State University
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov