Two-year Clinical and Radiographic Results with a Multidimensional, Expandable Interbody Implant in Minimally Invasive Lumbar Spine Surgery.

Introduction Minimally invasive spine surgery has become more prevalent in recent years, but the delivery of interbody devices with small footprints may insufficiently restore the disc space, which may lead to instability and non-union. Vertically expandable interbody implants have partially addressed this limitation, but lateral fusion support remains a concern. The purpose of this study was to evaluate two-year safety and effectiveness outcomes with a multidimensional, expandable interbody fusion device (Luna 3D Interbody Fusion System, Benvenue Medical, Inc., Santa Clara, CA) that is delivered through a minimally invasive approach (6-8 mm) that expands in situ to approximate an anterior lumbar interbody fusion footprint of 25 mm diameter. Material and methods This was a retrospective, single-center study that evaluated the clinical utility of a multi-expandable interbody cage in patients undergoing posterior or transforaminal lumbar interbody fusion. Key patient-reported outcomes included back pain severity, leg pain severity, and the Oswestry Disability Index (ODI). Radiographic assessments included disc height (anterior, posterior, and average), foraminal height, segmental lordosis, subsidence, implant migration, and pseudarthrosis. Patients were followed at regular intervals over two years postprocedure. Results A total of 50 consecutive patients were treated with transforaminal lumbar interbody fusion (TLIF) using the multidimensional expandable implant. Procedural blood loss was minimal (median 200 ml) and the mean hospital stay was 2.1 days. Perioperative complications were reported in three patients and included a dural tear, postoperative ileus, and end-plate violation. All complications were successfully managed conservatively. There were no nerve root injuries or perioperative infections. Over the two-year follow-up period, one case of subsidence and one case of implant migration were noted on radiographic imaging but required no treatment. Comparing the values reported at baseline and two years, the mean ODI score decreased by 61%, back pain severity decreased by 67%, and leg pain severity decreased by 80% (all p<0.001). Comparing radiographic measures from baseline to two years, anterior disc height increased from 7.6 mm to 15.5 mm, posterior disc height increased from 2.9 mm to 10.1 mm, average disc height increased from 5.6 mm to 13.3 mm, foraminal height increased from 12.2 mm to 20.2 mm, and segmental lordosis increased from 6.2 degrees to 14.0 degrees (all changes p<0.001). One case of non-union was observed and the corresponding two-year fusion rate was 98%. Conclusions The utilization of a minimally invasive, multidimensional, expandable interbody implant was safe and effective over two years of clinical follow-up. The implant allows the surgeon to re-establish sagittal balance and to provide a larger surface area for fusion as compared to traditional minimally invasive interbody devices.