Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for...
Spinal StenosisSpondylolisthesis1 moreThe purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.
The European Robotic Spinal Instrumentation (EUROSPIN) Study
Degenerative Disc DiseaseSpondylolisthesis5 moreIn a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.
PASS OCT® Post-market Clinical Follow-up
Intervertebral Disc DiseaseSpondylolisthesis3 moreProspective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months
Post-market Study of the TOPS™ System
Lumbar Spinal StenosisSpondylolisthesisThe study is being conducted to evaluate look the TOPS System when used in patients with degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates for spinal fusion.
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low...
Low Back PainSpondylolisthesis3 moreLumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis. Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device. In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.
Spine Registration Using 3D Scanning - Arise
Spinal FusionSpondylolisthesis2 moreThe primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
Prospective Study of Minimally Invasive Spine Surgery
Degenerative Disk DiseaseSpondylolisthesis2 moreThe population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease...
ScoliosisBack PainThe primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..
Spine Registration Using 3D Scanning
Spinal FusionSpinal Stenosis2 moreThe primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Degenerative Spine DiseaseSpondylolisthesis1 moreTo quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.