Comparing Outcomes of Anterior Cervical Discectomy and Fusion Using Structural Allograft or Tritanium C Device in Adults with Degenerative Disc Disease

What this Trial Is About

This research aims to observe and compare the outcomes of patients undergoing anterior cervical discectomy and fusion ACDF for degenerative disc disease. The study looks at two types of procedures one using a device called Tritanium C and the other using structural allograft bone with plates. It is a combined observational study including both retrospective and prospective data collection to evaluate fusion success and adverse events. The study involves two groups a retrospective cohort of up to 40 patients who previously received ACDF with structural allograft bone and plates, and a prospective group of 20 patients receiving Tritanium C as part of their standard care. Data includes patients treated at one or two contiguous cervical spine levels. The retrospective group will be matched to the prospective patients in a 21 ratio. Both cohorts have follow-up visits and imaging at baseline, 6 months, and 12 months post-operation to assess fusion and other outcomes. Participants will have clinical assessments including neck disability, neck and arm pain, and neurological status at baseline and during follow-up visits at 3, 6, and 12 months post-operation. Researchers will collect imaging and questionnaire data to measure fusion success and adverse events over time. The total participation period for retrospective patients includes up to one year of follow-up, while prospective patients are monitored through their standard care schedule. The study is conducted without blinding or randomization.

ACDF Using Structural Allograft vs. Tritanium C