NCT01269398

Unknown

GO-LIF With Percutaneous Facet Fusion

Hadassah Medical Organization Source

Compare

Other study identifiers

Sponsor study identifier

BARZ-004-HMO-CTIL

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

August 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

Not reported

Date not reported

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 Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
January 3, 2011
Actual (reported)
First Posted
January 4, 2011
Actual (reported)
Primary Completion
August 2014
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 22, 2013
Status Verified: March 2013
Last Update Submitted: March 21, 2013

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 SYSTEMSDevice

solid fusion, GO-LIF procedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Hadassah Medical Organization
Otherlead

Study Sites (1)

Hadassah Medical Organizaton

Jerusalem, 91120, Israel

Yair BarzilayCONTACT972-2-6776292 dbar@hadassah.org.il

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 2014

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 22, 2013

Record last verified: 2013-03

NCT05583864

Lumbar Fusion With Porous Versus Non-Porous Cages

Not ApplicableActive Not Recruiting

NCT01703338

Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery

Terminated

NCT06066879

Pre-Operative Ketamine Infusion for Post Operative Pain Control After Revision Spinal Surgery

Phase 4Unknown

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.
+22 more criteria

Contact the study team to confirm eligibility.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01269398
Data provider: ClinicalTrials.gov
Source updated: 2013-03-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:41 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

GO-LIF procedure, posetrior facets fusion

solid fusion, GO-LIF procedure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations