Bacterin and Titan Spine Products Perform Well in Study
Belgrade, Mont.-based Bacterin International Holdings Inc. and Mequon, Wis.-based Titan Spine LLC have received good news from a peer reviewed article that appeared in The International Journal of Spine Surgery. The study, titled “Transforaminal lumbar interbody fusion rates in patients using a novel titanium implant and demineralized cancellous allograft bone sponge,” reported positive results with the use of Bacterin’s OsteoSponge, a demineralized cancellous bone product for spinal fusion procedures, and Titan Spine’s Endoskeleton TT titanium cage and autograft bone.
Gerard Girasole, M.D., was the principle investigator for the journal article that evaluated OsteoSponge for interbody fusion in conjunction with Titan Spine’s Endoskeleton TT titanium cage and autograft bone. The study involved a set of patients evaluated at 6 months and a separate set of patients that were evaluated at 1 year post-op. An independent radiologist reviewed and graded the CT (computed tomography) scans for evidence on fusion and determined the fusion rates to be 41 of 44 (93.2 percent) for the 6 month group and 37 of 38 (97.4 percent) for the 12 month group. There were no radiographic device-related complications.
The impetus for the study, as stated in the abstract, was that traditional transforaminal lumbar interbody fusion (TLIF) with grafting and implant options like iliac crest bone graft (ICBG), recombinant bone morphogenetic protein (rhBMP), and polyetheretherketone (PEEK) cages have been reported to achieve extremely high fusion rates. Unfortunately, these options have also been frequently cited in the literature as causing postoperative morbidity and complications at a high cost. So the researchers sought to investigate TLIF using an acid-etched, roughened titanium cage (Titan Spine’s) that upregulates osteogenesis to see if similar fusion rates to those cited for ICBG, rhBMP, and PEEK cages could be safely achieved with minimal morbidity and complications.
Bacterin is an accredited tissue bank as well as a developer of spine products.