The Center for Spinal Disorders in partnership with the Spine Education and Research Institute (SERI) is focused on clinical research toward musculoskeletal problems and care. This integrated partnership provides access to substantial expertise and clinical data to support orthopaedic research. Our goal is to conduct clinical research that will translate to improvements in patient care and outcomes. Each research project undergoes a formal review by SERI’s community based Board of Directors and review by an outside Institutional Review Board, if required.
As part of our spine care research goals, The Center for Spinal Disorders in conjunction with the Spine Education and Research Institute publishes articles in leading spine journals around the world. All of the publications are in PDF format. You need Adobe Acrobat® Reader™ to view the following files:
THE USE OF COMPUTED TOMOGRAPHY ANGIOGRAPHY TO DEFINE THE PREVERTEBRAL VASCULAR ANATOMY PRIOR TO ANTERIOR LUMBAR PROCEDURES
Jason C. Datta, MD, Michael E Janssen, DO, Ruth Beckham, RN, BSN, and Caroline Ponce
Spine Education and Research Institute, Denver, CO
SPINE Volume 32, Number 1, pp 113-119
January 1, 2007
CERVICAL DISC REPLACEMENT vs. ACDF
Janssen, M. E., D.O., Alan S. Hilibrand, M.D., and Jeffrey C. Wang, M.D.
Spine Education and Research Institute and Center for Spinal Disorders, PC, Denver, CO
SpineLine, Current Concepts, pp 17-21
FUSION X DISC REPLACEMENT FOR DISCOGENIC PAIN
Michael E. Janssen, DO and Chi Lam, MS
Center for Spinal Disorders, P.C. and Spine Education and Research Institute, Denver, CO
AO Dialogue Controversies
Pfizer Begins Phase 2b Study Of Its Investigational Multi-antigen Staphylococcus aureus Vaccine In Adults Undergoing Elective Spinal Fusion
Surgical Site Infections (SSIs) are a significant and growing concern. SSIs caused by S. aureus account for approximately 20 percent of all SSIs in the U.S., and are associated with an estimated annual treatment cost of $12.3 billion in the U.S.2,3 Patients who suffer such infections due to antibiotic resistant (MRSA) or antibiotic sensitive (MSSA) S.aureus have worse clinical outcomes, including increased mortality in comparison with non-infected patients.“We are pleased to take this important next step in the development of our S. aureus vaccine,” said Dr. Kathrin Jansen, senior vice president and chief scientific officer of Vaccine Research and Development for Pfizer. “To date, there is no licensed vaccine available to prevent invasive S. aureus disease. We believe results from this study, if positive, will bring us closer to a potential preventive measure for this challenging disease that is associated with considerable morbidity and mortality.”
The primary outcome of the study, with an estimated enrollment of 2600 subjects, will measure the number of subjects in each treatment group with postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 90 days after elective posterior instrumented lumbar spinal fusion. Secondary outcomes will also measure postoperative S. aureus blood stream infections and/or deep incisional or organ/space surgical site infections occurring within 180 days after surgery, and postoperative S. aureus surgical site infections occurring within 90 and 180 days after elective posterior instrumented lumbar spinal fusion. Estimated completion of the study is 2017. More information on the trial can be found at: https://clinicaltrials.gov/
Pfizer’s S. aureus vaccine was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2014. The Fast Track process facilitates the development and expedites the review of drugs which treat severe conditions and fulfill an unmet medical need.5 Fast Track designation also enables Pfizer to continue to have ongoing discussions with the FDA on the development of its S. aureus vaccine.
About Staphylococcus aureus Investigational Vaccine
Pfizer’s multi-antigen S. aureus vaccine is designed to prevent a wide-range of clinical disease manifestations, caused by S. aureus, by facilitating killing of the bacteria at the early stages of invasive infection by targeting multiple virulence mechanisms.
About Staphylococcus aureus
Staphylococcus aureus is a leading cause of healthcare-associated infections, resulting in a substantial burden to health care systems. It is a particularly challenging pathogen, with an arsenal of virulence factors that enable host immune evasion and resistance to antibiotics. S. aureus has the potential to induce a wide spectrum of clinical manifestations, ranging from mild skin infections to deep wound and surgical site infections, bacteremia and sepsis, potentially leading to death.