Abstract
Introduction
Perform a retrospective review of a single site experience with the STALIF-C (Centinel Spine) integrated cervical fusion device and OsteoCel + stem cell–derived allograft material (NuVasive, Inc.).
Material and Methods
We reviewed all charts of patients undergoing an anterior cervical discectomy and fusion (ACDF one, two, and three levels), utilizing the STALIF-C device and Osteocel + bone graft material. Data comprised patients from January 2012 to April 2014, with an average final imaging follow-up of 5 months. All patients underwent the ACDF by the same surgeon at the same institution. Fusion criteria were assessed primarily by thin cut CT scans with multimodal reconstructions, but also with dynamic X-rays if CT imaging was unavailable. We implemented a standardized CT fusion criteria, for which all images were read by an independent Board Certified Neuroradiologist. Criteria for fusion was based on a grade 1 to 5 scale (CT imaging), and/or no movement on dynamic X-rays of greater than 2 degrees.
Results
A total of 101 patients were included in the study, with imaging and clinical follow-up obtained in 101 patients (100%). There were 39 males and 62 females, with an average age of 54. The break down in the number of levels treated was as follows: One level (49%), two levels (36%), and three levels (15%). Overall, 14% of the patients were active smokers, 11% had a history of former nicotine abuse, and 74% were nonsmokers. All the follow-up fusion assessments were done with thin cut CT scans with sagittal and coronal reconstructions, and dynamic X-rays. The fusion rates for the levels treated were as follows: one level (98%), two levels (94%), and three levels (87%). The integrated fusion rate was 95% without separating the procedures by levels. There were no incidents of hardware failure or break, with only one patient requiring a posterior cervical fusion for symptomatic pseudoarthrosis (multilevel fusion patient).
Conclusion
The STALIF-C integrated cervical fusion device, in conjunction with Osteocel + stem cell–derived bone graft material is a safe, effective, and reproducible fusion construct in the treatment of cervical degenerative disc disease. The rates of fusion, as compared with systematic meta-analyses in the literature, are comparable and in some cases superior to reported rates using standard cervical plating and cage constructs. To the best of our knowledge, this is the largest review analysis of any integrated cervical fusion device.