NuVasive (NUVA) enrolled the first patients in a prospective, multicenter postmarket U.S. study evaluating advanced spinal implants used in XLIF® procedures.
The 300-patient study will compare outcomes between traditional smooth PEEK intervertebral spacers and two devices from NUVA's Advanced Materials Science™ portfolio: Modulus® 3D-printed titanium and Cohere® Porous PEEK™. Further, each implant group will be randomized between Osteocel® Pro and cancellous allograft chips with bone marrow aspirate. At two years, a minimum of 10 surgeon investigators will measure the progression of fusion.
Overall, the study will evaluate success by comparing the rate of fusion, complications profile and any relationships between clinical (pain and function) and radiographic outcomes (fusion rate) among the three patient groups. Study completion is expected in 2022.