San Diego, California-based NuVasive, Inc. has announced that it is undertaking a new prospective, multicenter study which intends to evaluate advanced spinal implants used in XLIF (lateral lumbar interbody fusion) procedures and their long-term (2 years plus) effect on patient outcomes. The company intends to include at least 10 surgeon investigators and enroll approximately 300 patients across the U.S.
NuVasive explained the study methodology to OTW saying, “This study will evaluate and compare the clinical and radiographic outcomes between traditional smooth PEEK [polyetheretherketone] intervertebral spacers and two implants within the NuVasive Advanced Materials Science (AMS) portfolio, Modulus 3D-printed titanium and Cohere Porous PEEK, in patients who undergo a one- or two-level XLIF procedure. In addition, within each implant group, randomization between Osteocel Pro and cancellous allograft chips with bone marrow aspirate will allow for procedural comparisons using Level I biologic outcome evidence.”
“This is one of the most ambitious post-market studies undertaken by a spine company, and NuVasive is proud to partner on this initiative with key opinion leaders at some of the premier institutions in spine,” said Kyle Malone, head of Medical Affairs for NuVasive. “This study confirms NuVasive’s commitment to cultivating objective insights on implants with surface technology, and this work will provide key comparative, clinical evidence to build out smarter, more reproducible surgical solutions to improve the overall quality of care.”
Kyle Malone said, “NuVasive wants surgeons to know how differentiating and ambitious this study is—it reaffirms NuVasive’s deep commitment to not just creating game-changing innovation, but investing in significant, comparative clinical research designed to prove the clinical value of advanced surface implants, such as NuVasive’s Modulus 3D-printed titanium or Cohere Porous PEEK, over traditional implants. Many companies currently rely on pre-clinical along with short follow-up, non-comparative data to suggest implant superiority. NuVasive is committed to collecting objective insights to build out smarter solutions.”
