NuVasive has announced the results of a study supporting the use of Attrax Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion (PLF). The study, “Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial” were published online in Spine. Supported by the results of this study, NuVasive received US Food and Drug Administration (FDA) 510(k) clearance for expanded use of Attrax Putty without autograft.
“A study of this quality immediately differentiates Attrax Putty from other biologics on the market,” said Matt Link, president of NuVasive. “Attrax has proven the critical role surface optimization plays in the effectiveness of bone grafting technology, and underscores the NuVasive approach to developing innovative solutions which deliver positive clinical outcomes for surgeons and their patients.”
The trial enrolled 100 patients across four hospital centres where they underwent an instrumented PLF procedure. Following randomisation, Attrax Putty was applied to one side of the spine and iliac crest autograft and local bone was applied to the contralateral side, with each patient serving as their own control. Fusion was assessed by blinded observers at one year with CT scans showing fusion rates of 55 percent for the Attrax Putty side and 52 percent for the autograft side, with an overall fusion rate of 71 percent of levels. Attrax Putty alone successfully demonstrated non-inferior fusion performance compared to autograft in instrumented PLF.
“With increased focus on value-based medicine, surgeons and hospitals seek improved evidence when choosing a biologic for spinal fusion,” said Tyler Koski, associate professor of neurological surgery and orthopedic surgery at Northwestern Memorial Hospital (Chicago, USA). “Most data for bone graft materials is of lower quality and supports their use as bone graft extenders combined with autograft. The fact that Attrax Putty by itself demonstrates non-inferiority to autograft, the gold standard for bone grafts, speaks to the power of its unique surface technology, and with this study, I’m better informed in my clinical decision-making.”
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler for the repair of bone defects. This proprietary, advanced biomaterial features a surface microarchitecture which provides an instructive environment for bone formation without added cells or growth factors. The moldable graft material is resorbed and replaced by bone during the healing process.