Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

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.

This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft.

This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.

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)