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.
Study Type
OBSERVATIONAL
Enrollment
58
DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM
The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohio, United States
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
Time frame: 24 months
NRS
Numeric Rating Scale for neck and arm pain
Time frame: 24 months
NDI
Neck Disability Index
Time frame: 24 months
SF36 RAND
Short Form 36 RAND
Time frame: 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)
Time frame: 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.
Time frame: 24 months
Reoperation
Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added
Time frame: 24 months
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number of days in the hospital
number of days in the hospital
Time frame: up to 24 months
Adverse events
wound infection, dysphagia, hematoma, dysphonia, DVT, etc
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Neurological assessment: Hoffman's and Spurlings
Testing for positive or negative indication
Time frame: 24 months