This is an observational, descriptive, prospective and retrospective data collection study. The purpose of this study is to observe radiographic outcomes of patients who will undergo anterior cervical discectomy and fusion (ACDF) utilizing Tritanium C (Stryker Spine). The rate of fusion success and adverse events will be compared retrospectively to patients who underwent instrumented ACDF utilizing structural allograft bone with plates.
Males or females ≥18 years of age, ≤ 80 years of age
Subject is skeletally mature
Subject is diagnosed with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 -T1 disc
Subject has received six weeks of non-operative therapy i.e. injections, physical therapy, oral steroids
Presence of an infection systemic or local
Presence of marked local inflammation
Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
Use of bone growth stimulator
Parallel
Structural allograft
Procedure/SurgerySubjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
Tritanium C
DeviceSubjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Time to the presence of fusion
Antero-posterior and lateral plain radiographs
Neck disability
Neck Disability Index (NDI): Subjects will designate a statement that best describes their level of disability for each section of the survey. Statements are then ranked from 0-5, where 0 is a better outcome and 5 is a worse outcome. All rankings are totaled for a final score.
Neck and arm pain
Visual Analog Scale (VAS) for neck and arm pain: Subjects will designate a score to represent their pain from 0 to 10. 0 is indicative of no pain and 10 is indicative of the worst possible pain.
Incidence of sensory deficits
Yes or no response to: Sensory deficit at the surgical level, sensory deficit at an adjacent level to the surgical level, sensory deficit at a different level to the surgical level, any sensory deficit during follow-up
Incidence of motor deficits
Yes or no response to: Motor deficit at the surgical level, motor deficit at an adjacent level to the surgical level, motor deficit at a different level to the surgical level, any motor deficit
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