About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Structural allograft
- Tritanium C