Achieving Solide Fusion, Comibing the GO-LIF Procedure for Spinal Fixation and Stabilization With Percutaneous Posetrior Facets Fusion.

Hadassah Medical Organization1 site in 1 countryJanuary 4, 2011

ConditionsLumbar Fusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lumbar Fusion
Sponsor: Hadassah Medical Organization
Locations: 1
Primary Endpoint: percutaneous posetrior facets fusion
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 4, 2011

End Date

August 2014

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hadassah Medical Organization

Eligibility Criteria

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:
•Degenerative spondylolisthesis (Grades 1 and 2) in the sagittal plane with preserved or normal sagittal alignment
•Spinal stenosis (Not excluding patient with a need to decompression )
•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

Exclusion Criteria

•Lumbar hyperlordosis \> 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body
•Deformities of the vertebral bodies envisioned for instrumentation or the sacrum.
•Spondylolisthesis \> grade 2 acc. to Meyerding.
•Scoliosis and other deformities in the coronal plane.
•Fractures of the vertebrae envisioned for instrumentation.
•Osteoporosis or osteopenia (see below for examination criteria).
•Therapy with systemic corticosteroids or immunosuppressants.
•Bone metabolism diseases, such as osteomalacia or Paget's disease.
•Post inflammatory instability of the vertebral spine.
•State after radiation therapy of the relevant vertebral spine region.