Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs (NCT05696470) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
United States58 participantsStarted 2021-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years old
* Symptomatic 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 injury
* Previous cervical fusion surgery
* 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 (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-up
* Subjects who are pregnant or plan to become pregnant in the next 24 months
* Prisoner
* Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)