Overview
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.
Description
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.
Eligibility
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)