A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation - Full Text View

Sponsor:	Mazor Surgical Technologies, Ltd.
Information provided by:	Mazor Surgical Technologies, Ltd.
ClinicalTrials.gov Identifier:	NCT00810433

Purpose

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.

Condition	Intervention
Lower Back Pain	Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Clinical Safety and Feasibility Study of the GO-LIF® Approach

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Mazor Surgical Technologies, Ltd.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
The number of procedures that were not completed, and the reasons and causality for non-completions. [ Time Frame: Immediately post-op. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion 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. Other Names: Mazor SpineAssist GO-LIF

Arms

Assigned Interventions

Experimental: Arm 1

Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion

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.

Other Names:

Mazor
SpineAssist
GO-LIF

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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)
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

Exclusion Criteria:
1. Lumbar hyperlordosis > 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body 1.
2. Deformities of the vertebral bodies envisioned for instrumentation or the sacrum.
3. Spondylolisthesis > grade 2 acc. to Meyerding.
4. Scoliosis and other deformities in the coronal plane.
5. Fractures of the vertebrae envisioned for instrumentation.
6. Osteoporosis or osteopenia (see below for examination criteria).
7. Therapy with systemic corticosteroids or immunosuppressants.
8. Bone metabolism diseases, such as osteomalacia or Paget's disease.
9. Post inflammatory instability of the vertebral spine.
10. State after radiation therapy of the relevant vertebral spine region.
11. Current Marcoumar or heparin therapy for more than 6 months at the time of operation.
12. Malignant diseases with or without bone metastases.
13. Immunologic-inflammatory diseases (e.g., rheumatoid arthritis).
14. Diabetes mellitus.
15. Infectious diseases.
16. BMI > 30.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810433

Contacts

Contact: Guy Auerbach	+972-4-6270171 ext 128	guy@mazorst.com
Contact: Armin Schneier	+972-4-6270171 ext 110	armin@mazorst.com

Locations

Germany
Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)	Recruiting
Berlin, Germany, 12200
Contact: Olaf Prof. Dr. Süss, MD olaf.suess@charite.de
Principal Investigator: Robert schoenmayr, MD
Dep. Of Orthopedic Helios Rosmann Klinik	Recruiting
Breisach, Germany, 79206
Contact: Michael Pfeiffer, Prof. michael.pfeiffer@helios-kliniken.de
Principal Investigator: michael pfeiffer, MD
Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen	Not yet recruiting
Göttingen, Germany, 37075
Contact: Veit Prof. Dr. Rohde, MD veit.rohde@med.uni-goettingen.de
Dept. of Neurosurgery, Klinikum Nordstadt Hannover	Recruiting
Hannover, Germany, 30167
Contact: Burger ralf.burger@krh.eu
Dep. Of Neurosurgery Universitaetsklinikum Mannheim	Recruiting
Mannheim, Germany, 68167
Contact: Schmieder Kirsten.Schmieder@nch.ma.uni-heidelberg.de
Principal Investigator: Kirsten Schmieder, MD
Dep. Of Orthopedic Klinikum Grosshadern- LMU	Recruiting
Munich, Germany, 81377
Contact: Birkenmaier doctor-b@web.de
Principal Investigator: Christof Birkenmaier, MD
Dep. Of Neurosurgery Paracelsus kliniken	Recruiting
Munich, Germany, 81927
Contact: Dietl rupert.dietl@t-online.de
Principal Investigator: Rupert Dietl, MD
Krankenhaus Munchen Schwabing	Recruiting
Munich, Germany, 80804
Contact: Rene Hebecker, Dr. +49 89 30685617 rene.hebecker@klinikum-muenchen.de
Contact: Dieter Sackerer, Dr. +49 89 30685617 Dieter.Sackerer@kms.mhn.de
Israel
Dept. of Orthopedics, Carmel Medical Center	Not yet recruiting
Haifa, Israel, 34362
Contact: Roffman rofman_moshe@clalit.org.il
Principal Investigator: Moshe Roffman, MD
Dept. of Orthopedics Hadassah Medical Center - The Hebrew University	Not yet recruiting
Jerusalem, Israel, 91120
Contact: Liebergall liebergall@hadassah.org.il
Principal Investigator: Meir (Iri) Liebergall, MD

Sponsors and Collaborators

Mazor Surgical Technologies, Ltd.

Investigators

Study Director:

Isador H Lieberman, MD, MBA, FRCSC

Texas Back Institute

More Information

No publications provided by Mazor Surgical Technologies, Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Guy Auerbach, Mazor Robotics, Inc.
ClinicalTrials.gov Identifier:	NCT00810433 History of Changes
Obsolete Identifiers:	NCT00786955
Other Study ID Numbers:	CLN-102
Study First Received:	December 16, 2008
Last Updated:	February 6, 2011
Health Authority:	Israel: Ethics Commission Germany: Ethics Commission

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 24, 2012