GO-LIF With Percutaneous Facet Fusion

NCT01269398 | Unknown

• 1 other identifier: BARZ-004-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Fusion

Outcome Measures

Primary Outcomes (1)

• percutaneous posetrior facets fusion

  Fusion will be determined by and evaluated by the acheivement of a fusion and controled after 1 year by a CT

  1 year

Study Arms (2)

GO-LIF procedure, posetrior facets fusion

NO INTERVENTION

solid fusion, GO-LIF procedure

OTHER

ability to achieve solid fusion, comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous posetrior facets fusion

Device: GO-LIF and SpineAssist SYSTEMS

Interventions

GO-LIF and SpineAssist SYSTEMS DEVICE

solid fusion, GO-LIF procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 )
• 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

You may not qualify if:

• Lumbar hyperlordosis \> 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body 1.
• 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.
• Current Marcoumar or heparin therapy for more than 6 months at the time of operation.
• Malignant diseases with or without bone metastases.
• Immunologic-inflammatory diseases (e.g., rheumatoid arthritis).
• Diabetes mellitus.
• Infectious diseases.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organizaton

Jerusalem, 91120, Israel

Location

Central Study Contacts

Arik Tzukert, DMD

CONTACT

00 972 2 6776095; arik@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Primary Completion: August 1, 2014
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

IL (1)