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

Sponsored by:	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 feasdbilty 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

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Safety and Feasibility Study of the GO-LIF™ Approach

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 the SF-12 short form health survey. [ Time Frame: pre-op; 3, 6 and 12 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	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, 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 intorduce the GO-LIF screws for fixation of the spinal levels to be fused.

Arms

Assigned Interventions

Arm 1: Experimental

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, 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 intorduce the GO-LIF screws for fixation of the spinal levels to be fused.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients requiring single-level instrumented interbody fusion from L1 to S1, as indicated for mechanical or discogenic or idiopathic back pain or degenerative disc disease or instability.

Or any of criteria below:
1. 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)
2. Patients must have normal alignment of the spine in the coronal view.
The interbody fusion approach may be TLIF or PLIF or XLIF or ALIF or other, as clinically indicated.
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..
Patient is 18 years or more
Patient is willing and able to comply with study requirements

Exclusion Criteria:

Lumbar hyper-lordosis - greater than 70° between superior endplate of S1 and superior endplate of L1.
Sacral anomalies if fixation into sacrum is indicated.
The patient is paraplegic
Global spinal deformity, such as scoliosis with Cobb angle greater than 10°.
Infection or tumor, including focal infections such as discitis or osteomyelitis.
Osteoporotic bone structure - T-score of less than minus-2.5.
Vertebral body fractures in the affected vertebrae or those adjacent to them.
Obesity - Body Mass Index equal to or higher than 30.

Contacts and Locations

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

Contacts

Contact: Armin Schneier	+972-4-6270171 ext 110	armin@mazorst.com
Contact: Sagi Brink-Danan, MSc	+1-401-808-1154	sagi.brinkdanan@mazorst.com

Locations

Germany
Dep. Of Orthopedic Klinikum Grosshadern- LMU
Munich, Germany, 81377
Dep. Of Orthopedic Helios Rosmann Klinik
Breisach, Germany, 79206
Dep. Of Neurosurgery Paracelsus kliniken
Munich, Germany, 81927
Dep. Of Neurosurgery Klinikum Der Landeshauptstadt Wiesbaden - HSK
Wiesbaden, Germany, 65199
Dep. Of Neurosurgery Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Israel
Dept. of Neurosurgery & Orthopedics, Sheba Medical Center
(Tel-Hashomer) Ramat Gan, Israel, 52621
Dept. of Orthopedics, Carmel Medical Center
Haifa, Israel, 34362
Dept. of Orthopedics Hadassah Medical Center - The Hebrew University
Jerusalem, Israel, 91120

Sponsors and Collaborators

Mazor Surgical Technologies, Ltd.

Investigators

Study Director:

Isador H Lieberman, MD, MBA

Cleveland Clinic Spine Institute

More Information

Responsible Party:	MAzor Surgical Technologies, Inc. ( Armin Schneier )
Study ID Numbers:	CLN-102
Study First Received:	December 16, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00810433
Health Authority:	Israel: Ethics Commission; Germany: Ethics Commission

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on February 10, 2009