Clinical trial NCT00810433: A Clinical Study of the GO-LIF® Approach for Lumbar Spinal Fixation
Official title: A Clinical Safety and Feasibility Study of the GO-LIF® Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: Mazor Robotics
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.


Eligibility criteria: Inclusion Criteria

1. Men and women, 18-80 years of age.
2. The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
3. Unequivocal medical indication for the fixation surgery of a single motion segment of the lumbar spine.
4. 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:

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. 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.

Primary outcomes:
measure: The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.
timeFrame: prior to discharge from hospital
measure: Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.
timeFrame: Preferably prior to discharge from hospital, and no later than 1 month post-op
measure: The number of procedures that were not completed, and the reasons and causality for non-completions.
timeFrame: Immediately post-op.
Secondary outcomes:
measure: 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.
timeFrame: 3, 6 and 12 months post-op.
measure: Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire.
timeFrame: pre-op; 3, 6 and 12 months post-op
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
city: Breisach
country: Germany
facility: Dep. Of Orthopedic Helios Rosmann Klinik
city: Göttingen
country: Germany
facility: Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen
city: Hannover
country: Germany
facility: Dept. of Neurosurgery, Klinikum Nordstadt Hannover
city: Mannheim
country: Germany
facility: Dep. Of Neurosurgery Universitaetsklinikum Mannheim
city: Munich
country: Germany
facility: Krankenhaus Munchen Schwabing
city: Munich
country: Germany
facility: Dep. Of Orthopedic Klinikum Grosshadern- LMU
city: Munich
country: Germany
facility: Dep. Of Neurosurgery Paracelsus kliniken
city: Haifa
country: Israel
facility: Dept. of Orthopedics, Carmel Medical Center
city: Jerusalem
country: Israel
facility: Dept. of Orthopedics Hadassah Medical Center - The Hebrew University
Study officials:
affiliation: Texas Back Institute
name: Isador H Lieberman, MD, MBA, FRCSC
role: STUDY_DIRECTOR
References:
citation: 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.