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NCT05696470
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Conditions: Radiculopathy, Myelopathy Cervical, Foraminal Stenosis, Central Canal Stenosis
Sex: All
Ages: 18 Years – N/A
Enrollment: 58
Sponsor: Ohio State University
Location: United States
Summary
The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM.
This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.
Eligibility Criteria
Inclusion Criteria:≥ 18 years oldSymptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1).Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)Cervical x-rays at 24 months (±60 days; retrospective comparison group only)Exclusion Criteria:Traumatic spinal fractures or spinal cord injuryPrevious cervical fusion surgeryCo-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 investigatorSevere co-morbidities (e.g., heart, respiratory, or renal disease)Recent (<3 yrs) or co-incident spinal tumor or infectionConcurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only)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-upSubjects who are pregnant or plan to become pregnant in the next 24 monthsPrisonerOther contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)
Source: ClinicalTrials.gov (NCT05696470). StuddyBuddy aggregates publicly available trial information.