Lower Back PainNCT00810433
A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation
A study testing GO-LIF - Guided Oblique Lumbar Interbody Fusion in people with Lower Back Pain, run by Mazor Robotics at 10 sites in 2 countries.
Trial summary
The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- GO-LIF - Guided Oblique Lumbar Interbody Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2009to Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18-80 years of age.
- The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
- 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.
- Or any of criteria below:
- Patients with Grade II or Grade III spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S1. (Not excluding patient with a need to decompression)
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- Patients must have normal alignment of the spine in the coronal view. 2. The interbody fusion approach may be TLIF or PLIF or ALIF or other, as clinically indicated.
- 3. The procedure may be combined with a Micro-decompression and/or Micro-discectomy and/or direct or indirect decompression and/or laminectomy or laminotomy and/or other procedures, as clinically indicated - as long as such procedures do not compromise the structural integrity of the pedicles of the inferior vertebra or the vertebral body of either vertebra of the levels involved..
- 4. Patient is 18 years or more 5. Patient is willing and able to comply with study requirements
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.
- BMI > 30.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany8 sites
Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
Berlin, 12200
Dep. Of Orthopedic Helios Rosmann Klinik
Breisach, 79206
Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen
Göttingen, 37075
Dept. of Neurosurgery, Klinikum Nordstadt Hannover
Hanover, 30167
Dep. Of Neurosurgery Universitaetsklinikum Mannheim
Mannheim, 68167
Krankenhaus Munchen Schwabing
Munich, 80804
Dep. Of Orthopedic Klinikum Grosshadern- LMU
Munich, 81377
Dep. Of Neurosurgery Paracelsus kliniken
Munich, 81927
Israel2 sites
Dept. of Orthopedics, Carmel Medical Center
Haifa, 34362
Dept. of Orthopedics Hadassah Medical Center - The Hebrew University
Jerusalem, 91120
About this study
Official title: A Clinical Safety and Feasibility Study of the GO-LIF® Approach
The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.
- Conditions
- Lower Back Pain
- Being tested
- GO-LIF - Guided Oblique Lumbar Interbody Fusion
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO-LIF - Guided Oblique Lumbar Interbody FusionProcedure or surgery
Also called Mazor, SpineAssist, GO-LIF
All patients will undergo single-level instrumented interbody spinal fusion surgery with instrumentation.
Upon induction of general anesthesia, the patient will be positioned prone on a radiolucent operating table and prepared according to standard hospital procedure. An interbody fusion will be performed according to standard procedure and as indicated by the surgeon. The interbody fusion portion of the surgery will be carried out using any current technique - such as PLIF, TLIF, PLF, PLLF, XLIF or ALIF. The fusion strategy can be performed in an open or minimally invasive manner, as indicated. The interbody device will be inserted after the screws trajectory will be drilled and a 4.5mm Trajectory holder is in place. This will assure the surgeon that no collision will occur between the interbody and the screws.
Upon completion of the fusion stage of the surgery, SpineAssist will be used to introduce the GO-LIF screws for fixation of the spinal levels to be fused.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.
Measured: prior to discharge from hospital
Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.
Measured: Preferably prior to discharge from hospital, and no later than 1 month post-op
The number of procedures that were not completed, and the reasons and causality for non-completions.
Measured: Immediately post-op.
Secondary outcomes (2)
Plain AP, Lateral and flexion-extension radiographs. The radiographs will be examined for: • Evidence of bridging trabecular bone between the involved motion segments • Translational motion <3mm; and •Angular motion <5 degrees.
Measured: 3, 6 and 12 months post-op.
Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire.
Measured: pre-op; 3, 6 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazor Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isador H Lieberman, MD, MBA, FRCSC, Study director, Texas Back Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810433
- Sponsor's protocol ID
- CLN-102
- Status last verified
- Feb 2014
- First submitted
- 16 Dec 2008
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Birkenmaier C, Suess O, Pfeiffer M, Burger R, Schmieder K, Wegener B. The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF). BMC Musculoskelet Disord. 2010 Sep 6;11:199. doi: 10.1186/1471-2474-11-199.
PubMed 20819219
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety and Feasibility Study of the GO-LIF® Approach
- ClinicalTrials.gov ID
- NCT00810433
- Acronym / sponsor ID
- CLN-102
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mazor RoboticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Dec 2008 (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.
The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, 18-80 years of age.
- The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
- 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.
- Patients with Grade II or Grade III spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S1. (Not excluding patient with a need to decompression)
Key exclusion criteria (16 listed)
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 - Guided Oblique Lumbar Interbody FusionAlso: Mazor, SpineAssist, GO-LIFAll patients will undergo single-level instrumented interbody spinal fusion surgery with instrumentation. Upon induction of general anesthesia, the patient will be positioned prone on a radiolucent operating table and prepared according to standard hospital procedure. An interbody fusion will be performed according to standard procedure and as indicated by the surgeon. The interbody fusion portion of the surgery will be carried out using any current technique - such as PLIF, TLIF, PLF, PLLF, XLIF or ALIF. The fusion strategy can be performed in an open or minimally invasive manner, as indicated. The interbody device will be inserted after the screws trajectory will be drilled and a 4.5mm Trajectory holder is in place. This will assure the surgeon that no collision will occur between the interbody and the screws. Upon completion of the fusion stage of the surgery, SpineAssist will be used to introduce the GO-LIF screws for fixation of the spinal levels to be fused. | Procedure or surgery | Arm 1 |
Primary outcome
The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.
Time frame: prior to discharge from hospital
Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.
Time frame: Preferably prior to discharge from hospital, and no later than 1 month post-op
The number of procedures that were not completed, and the reasons and causality for non-completions.
Time frame: Immediately post-op.
2 secondary outcomes
Plain AP, Lateral and flexion-extension radiographs. The radiographs will be examined for: • Evidence of bridging trabecular bone between the involved motion segments • Translational motion <3mm; and •Angular motion <5 degrees.
Time frame: 3, 6 and 12 months post-op.
Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire.
Time frame: pre-op; 3, 6 and 12 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Derived from this study: PubMed 20819219Birkenmaier C, Suess O, Pfeiffer M, Burger R, Schmieder K, Wegener B. The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF). BMC Musculoskelet Disord. 2010 Sep 6;11:199. doi: 10.1186/1471-2474-11-199.
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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.
Isador H Lieberman, MD, MBA, FRCSC study director
Texas Back Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO-LIF - Guided Oblique Lumbar Interbody Fusion in people with Lower Back Pain, run by Mazor Robotics at 10 sites in 2 countries.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury. (time frame: prior to discharge from hospital). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810433, which also lists 1 linked publication.
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 7 Feb 2014.