Lawrence, Brandon D.

Study Design: A national prospective cervical spine surgery registry was developed to archive radiographic studies, patient-reported outcome measures (PROMs), and surgical implant data to assess long-term safety. Objective: To describe the design, development, funding, and implementation of a cervical spine data registry for 1000 patients with myelopathy and radiculopathy. Summary of Background Data: While surgery for cervical radiculopathy and myelopathy is safe and effective, there is significant practice variation among spine surgeons. While randomized clinical trials (RCTs) can provide high-quality comparative effectiveness data, RCTs lack the ability to evaluate the safety and effectiveness of various surgical procedures and implants among heterogenous real-world patient populations. The CSRS Registry was designed to collect patient demographics, outcomes, radiographic imaging, surgical approach, and implant data for the purpose of conducting high-quality research. Methods: Patients with cervical myelopathy or radiculopathy were enrolled in the CSRS National Registry. De-identified patient data, validated PROMs, radiographic data, and implant data were collected from multiple clinical sites across the United States. Results: One thousand patients [mean age, 58 y; 456 (46%) women] were enrolled, with 31% follow-up at 1 year. Five hundred ninety-two patients were diagnosed with radiculopathy, 252 with myelopathy, and 156 with radiculopathy and myelopathy. Patients had significant improvements in their PROMs after surgery. At 1 year, the mean NDI score improved from 37.2 to 20.9 ( P <0.001). The mean self-reported P-mJOA score at baseline was 14.2 and improved to 15.2 by 1 year ( P <0.001). Baseline CSDI score was 23.6 and improved with a 1-year decrease to an average score of 13.6 ( P <0.001). There was significant improvement in PROMIS-10 Physical Health score from 41.0 to 45.9 (n=311; P <0.001) at 1-year follow-up. Conclusions: The CSRS Registry has successfully collected clinical outcomes data that is being leveraged for comparative effectiveness research and evaluations of the long-term safety and effectiveness of spinal implants.

Study Design: Literature review. Objectives: A review of the literature identifying preoperative risk factors for developing surgical site infections after spine surgery and discussion of the preventive strategies to minimize risks. Methods: A review of the literature and synthesis of the data to provide an updated review on the preoperative management of surgical site infection. Results: Preoperative prevention strategies of reducing surgical site infections in spine surgery remains a challenging problem. Careful mitigation of modifiable patient comorbidities, blood glucose control, smoking, obesity, and screening for pathologic microorganisms is paramount to reduce this risk. Individualized antibiotic regimens, skin preparation, and hand hygiene also play a critical role in surgical site infection prevention. Conclusions: This review of the literature discusses the preoperative preventive strategies and risk management techniques of surgical site infections in spine surgery. Significant decreases in surgical site infections after spine surgery have been noted over the past decade due to increased awareness and implementation of the prevention strategies described in this article. However, it is important to recognize that prevention of surgical site infection requires a system-wide approach that includes the hospital system, the surgeon, and the patient. Continued efforts should focus on system-wide implementation programs including careful patient selection, individualized antibiotic treatment algorithms, identification of pathologic organisms, and preoperative decolonization programs to further prevent surgical site infections and optimize patient outcomes.