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Utilization of trans-pedicular trans-discal implants for stabilization of a single lumbar motion segment, in conjunction with posterior facets fusion. The trajectories are planned and achieved by means of the SpineAssist® system - a computerized, image-based guidance system that assists surgeons in precisely guiding spinal surgical tools and implants in line with a CT-based pre-operative plan. GO-LIF and SpineAssist are CE marked products.
Thy study's objective is to to collect data regarding the ability to achieve solide fusion, comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous posterior facets fusion.
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Inclusion criteria
Skeletally-mature patients requiring single-level instrumented fusion from L1 to S1
Men and women, 18-80 years of age.
Unequivocal medical indication for the fixation surgery of a single motion segment of the lumbar spine.
Correct coronal profile of the lumbar spine. An asymmetric collapse of the disk space in the coronal plane between the vertebral bodies envisioned for instrumentation is by itself not an exclusion criterion.
Patient may have, but is not required to, secondary diagnosis of any one of the following:
ODI cut-off for inclusion, lower than or equal to 40 for ODI
VAS cut-off for inclusion, lower than or equal to 9
Patient is willing and able to comply with study requirements, including follow-up schedule and postoperative management program
Patient must understand and sign informed consent
Exclusion criteria
0 participants in 2 patient groups
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Central trial contact
Arik Tzukert, DMD
Data sourced from clinicaltrials.gov
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