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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Radiculopathy, Myelopathy Cervical, Foraminal Stenosis, Central Canal Stenosis

Intervention / Treatment
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* Device: DePuy Synthes Conduit 3D printed titanium cages


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DePuy Synthes Conduit 3D printed titanium cages|DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | based on postoperative X-ray: presence of bone trabeculae across graft-host interface, absence of radiolucent gap between graft and adjacent vertebral body, restriction of motion to 2mm or less between adjacent vertebral spinous processes on flexion-extension lateral radiographs | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS | Numeric Rating Scale for neck and arm pain | 24 months | 
| NDI | Neck Disability Index | 24 months | 
| SF36 RAND | Short Form 36 RAND | 24 months | 
| Neurological assessment: Upper Extremity Strength | grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT) | 24 months | 
| Cervical sagittal alignment | Standing radiographs of the sagittal spine to identify changes in functional sagittal; will measure the Cobb angle between the lower endplate of C2 and C7 (C2L-C7L angle) alignment after cervical fusion as determined by functional segments between cervicothoracic and thoracolumbar. Patient cervical 4 view x-rays pre-operatively and at follow-ups will be compared. | 24 months | 
| Reoperation | Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added | 24 months | 
| number of days in the hospital | number of days in the hospital | up to 24 months | 
| Adverse events | wound infection, dysphagia, hematoma, dysphonia, DVT, etc | 24 months | 
| Neurological assessment: Sensory function (C2-C7 dermatome) | Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper. | 24 months | 
| Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2) | Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes. | 24 months | 
| Neurological assessment: Hoffman's and Spurlings | Testing for positive or negative indication | 24 months |