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

Not Applicable

Completed

• Conditions: Lower Back Pain
• Interventions: Procedure: GO-LIF - Guided Oblique Lumbar Interbody Fusion

• Registration Number: NCT00810433
• Lead Sponsor: Mazor Robotics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	GO-LIF - Guided Oblique Lumbar Interbody Fusion	-

Primary Outcome Measures

Name	Time	Method
The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.	prior to discharge from hospital
Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.	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.	Immediately post-op.

Secondary Outcome Measures

Name	Time	Method
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.	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.	pre-op; 3, 6 and 12 months post-op

Trial Locations

Locations (10)

Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen; 🇩🇪 Göttingen, Germany

Dep. Of Neurosurgery Paracelsus kliniken; 🇩🇪 Munich, Germany

Dept. of Orthopedics, Carmel Medical Center; 🇮🇱 Haifa, Israel

Dept. of Orthopedics Hadassah Medical Center - The Hebrew University; 🇮🇱 Jerusalem, Israel

Dept. of Neurosurgery, Klinikum Nordstadt Hannover; 🇩🇪 Hannover, Germany

Dep. Of Orthopedic Helios Rosmann Klinik; 🇩🇪 Breisach, Germany

Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF); 🇩🇪 Berlin, Germany

Krankenhaus Munchen Schwabing; 🇩🇪 Munich, Germany

Dep. Of Orthopedic Klinikum Grosshadern- LMU; 🇩🇪 Munich, Germany

Dep. Of Neurosurgery Universitaetsklinikum Mannheim; 🇩🇪 Mannheim, Germany