WEST CHESTER, PA — Centinel Spine, LLC announced the recent publication of a research study on its STALIF C-Ti product in the Journal of Surgery & Anesthesia Research: “Preliminary 12-Month Safety and Efficacy Outcomes for the Treatment of Cervical Radiculopathy and Myelopathy with the Stalif-C Integrated Interbody Fusion Device.”1 The prospective multi-center study supports that patients receiving STALIF C-Ti implants demonstrated significant improvements in clinical outcome scores with minimal overall complication rate.
The clinical study utilizing the STALIF C-Ti integrated cage-screw implants was performed in 145 patients and 12-month outcome scores demonstrated significant improvement in all available patient reported outcome scores collected (p<0.05 for all), including NDI, VAS neck, VAS left arm, and VAS right arm.
Co-investigator on the study Jad G. Khalil, MD of Michigan Orthopaedic Surgeons commented, “This is what I believe to be a very important multi-center study on stand-alone devices. There is very little data on stand-alone devices. And, while reference is frequently made comparing cervical fusions, the majority of those references are comparing plated fusions. This study was undertaken to determine if there was an advantage to an Integrated Interbody device over traditional plated fusion. The study was conducted at eleven centers across the country—a mix of private practice and university-based programs, with all data collected and entered into a validated database.” Dr. Khalil concluded, “I believe this study will be very important in influencing fusion device selection and is long overdue.”
Centinel Spine’s CEO, Steve Murray, stated, “We are committed to providing clinical evidence to support our portfolio of devices and this study is one of the few multi-center prospective clinical evaluations of this type of technology. We are dedicated to advancing evidence that further supports the stand-alone fusion platform that was pioneered by Centinel Spine.”
The STALIF C-Ti implant technology has been engineered based on the STALIF design, which has a history of over 30 years of clinical usage and has helped thousands of patients regain their lives. STALIF implants provide compressive fixation at the fusion site, pulling the vertebral bodies onto the implant and graft material to enhance opportunities for fusion in line with Wolff’s Law of Bone Healing.
1 Barrett Boody, Jad Khalil, Betsy Grunch, Michael Musacchio, Amir Vokshoor, et al (2021) Preliminary 12-Month Safety and Efficacy Outcomes for the Treatment of Cervical Radiculopathy and Myelopathy with the Stalif-C Integrated Interbody Fusion Device. Journal of Surgery & Anesthesia Research. SRC/JSAR-133. DOI: https://doi.org/10.47363/JSAR/2021(2)128.
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