Evidence comes in many forms – with personal experience being the most credible. But before personal experience can be gathered, most bone graft materials must be evaluated under the regulation of the FDA. Tissue products (cellular bone matrices and simple allografts) are not required to provide any clinical proof of safety or performance to the FDA. Evidence supporting device products (formulated DBMs and synthetics) must compare favorably in animal studies to a similar bone graft material already on the market. A drug/device combination (peptide bone matrix and rhBMP) is proven in a human clinical trial.
The U.S. FDA IDE pivotal clinical study was a prospective, randomized, multicenter study comparing i-FACTOR Putty to autologous bone (control) in patients with degenerative cervical disc disease who underwent a single-level instrumented anterior discectomy and fusion procedure. Patient enrollment was completed in May 2013 with a total of 319 patients participating in the study. The key study results – Fusion Rates, Neck Disability Index (NDI), Neurological Outcome, and Complication Rates – were assessed at 12 months after surgery. Most of the patients in the study have been followed for up to six years. The one-year results of this study have been published in the peer-reviewed journal Spine.