Lumbar FusionNCT01269398
GO-LIF With Percutaneous Facet Fusion
A study testing GO-LIF and SpineAssist SYSTEMS in people with Lumbar Fusion, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Fusion
- What is being tested?
- GO-LIF and SpineAssist SYSTEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Patient must understand and sign informed consent
Who cannot join
- 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).
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- 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.
- More than one motion segments requiring treatment.
- Prior percutaneous vertebral augmentation procedure (e.g., vertebroplasty, kyphoplasty) at index or adjacent level.
- Prior fusion attempts at the involved levels.
- Clinically or radiographically compromised vertebral bodies at the superior vertebra of the affected level or compromised pedicles at the inferior vertebra of the affected level due to current or past trauma such that a Onyx Spinal System can not be implanted
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.
- Coagulopathy or inability to reverse anti-coagulant therapy (both during and approximately 24 hours post-procedure).
- Metabolic bone disease such as Paget's disease, osteopenia or osteomalacia.
- Severe diabetes mellitus requiring daily insulin management.
- Haemorrhagic diasthesis.
- Coagulation disorders, or severe cardiopulmonary disease.
- Active systemic infection (including AIDS, HIV and Hepatitis) or active infection at surgical site.
- Rheumatoid arthritis or other autoimmune disease.
- Morbid obesity, defined as having a Body Mass Index of 40 or higher or more than 100 pounds over weight.
- Conditions or medications that may interfere with bony/soft tissue healing (e.g., long term steroid use).
- Any medical condition that would preclude the patient from having surgery, impede the benefit of spinal implant surgery or impede the patient from completing the post operative rehabilitation plan.
- Pregnancy, current or planned during the duration of the study.
- Subject has a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol) within the last 12 months.
- Known allergy to titanium or titanium alloys.
- Bone growth stimulator use anywhere in the body within the last 30 days.
- In active spinal litigation.
- Degenerative spondylolisthesis (Grades 3 and above)
- Is currently involved in a study of another investigational product for similar purpose
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organizaton
Jerusalem, 91120
Yair Barzilay, 972-2-6776292, dbar@hadassah.org.il
About this study
Official title: Achieving Solide Fusion, Comibing the GO-LIF Procedure for Spinal Fixation and Stabilization With Percutaneous Posetrior Facets Fusion.
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
- Being tested
- GO-LIF and SpineAssist SYSTEMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-LIF and SpineAssist SYSTEMSDevice
| Study group | Role | What they receive |
|---|---|---|
| GO-LIF procedure, posetrior facets fusion | No intervention | Not described |
| 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 Receives: Device: GO-LIF and SpineAssist SYSTEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar FusionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269398
- Sponsor's protocol ID
- BARZ-004-HMO-CTIL
- Status last verified
- Mar 2013
- First submitted
- 3 Jan 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Solide Fusion, Comibing the GO-LIF Procedure for Spinal Fixation and Stabilization With Percutaneous Posetrior Facets Fusion.
- ClinicalTrials.gov ID
- NCT01269398
- Acronym / sponsor ID
- BARZ-004-HMO-CTIL
- Conditions
- Lumbar Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Primary completion
- Aug 2014 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GO-LIF procedure, posetrior facets fusion | No intervention | – |
| solid fusion, GO-LIF procedure | Other | Device: GO-LIF and SpineAssist SYSTEMSability to achieve solid fusion, comibing the GO-LIF procedure for spinal fixation and stabilization with percutaneous posetrior facets fusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GO-LIF and SpineAssist SYSTEMS | Device | solid fusion, GO-LIF procedure |
Primary outcome
percutaneous posetrior facets fusion
Time frame: 1 year
Fusion will be determined by and evaluated by the acheivement of a fusion and controled after 1 year by a CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-LIF and SpineAssist SYSTEMS in people with Lumbar Fusion, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzukert, DMD (00 972 2 6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percutaneous posetrior facets fusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.