In the first head to head, peer reviewed, published study, patients undergoing LLIF/TLIF procedures with OsteoAMP showed higher fusion rates and reduced supply costs when compared to patients undergoing the same procedures with rhBMP-2 (Infuse, Medtronic). The study of 321 patients at three centers was published in The Journal of Orthopaedic Surgery and Research and provides clinical/radiographic evidence of superior fusion rates for OsteoAMP in comparison to rhBMP-2.
Radiologic review and evaluation, assessed at various time points, was conducted by an independent radiologist blinded to intervention, product and surgeon information. The analysis indicated fusion rates for the OsteoAMP patients displayed statistically significant superiority over rhBMP-2 patients at 6, 12, and 18 months (p<0.01).
In addition, OsteoAMP provided cost savings as it was approximately 74% less expensive, per level and per patient, than rhBMP-2.
OsteoAMP has been a part of my practice since 2009 and has become my primary osteobiologic," said Dr. Jeffery Roh, lead author of the study. "My patients complain less of radiculitis and feel better faster. Using OsteoAMP has reduced my worry of long-term consequences when using rhBMP-2."
Amit Govil, president of Advanced Biologics also commented, "As a company, our aim is to provide a product that’s value to surgeon, hospital and patient is based on sound clinical analysis, rather than irrelevant testing models that are the norm in the industry. Rather than attempt to substantiate our technologies via basic animal studies or clinical data with undersized patient populations, we have continued to expand our data set for OsteoAMP further validating its efficacy."
Advanced Biologics is currently finalizing clinical sites for a new study titled, ‘A Prospective, Randomized Study of Instrumented, Posterolateral Spinal Fusions with OsteoAMP versus Autograft’. The study has established Rush University Medical Center and West Virginia University as multiple principal investigators (PI).