Back to results

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

Primary Purpose

Lower Back Pain

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

GO-LIF - Guided Oblique Lumbar Interbody Fusion

About this trial

This is an interventional treatment trial for Lower Back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
Dep. Of Orthopedic Helios Rosmann Klinik
Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen
Dept. of Neurosurgery, Klinikum Nordstadt Hannover
Dep. Of Neurosurgery Universitaetsklinikum Mannheim
Krankenhaus Munchen Schwabing
Dep. Of Orthopedic Klinikum Grosshadern- LMU
Dep. Of Neurosurgery Paracelsus kliniken
Dept. of Orthopedics, Carmel Medical Center
Dept. of Orthopedics Hadassah Medical Center - The Hebrew University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.

Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.

The number of procedures that were not completed, and the reasons and causality for non-completions.

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.

Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire.

Full Information

NCT ID

NCT00810433

First Posted

December 16, 2008

Last Updated

February 6, 2014

Sponsor

Mazor Robotics

1. Study Identification

Unique Protocol Identification Number

NCT00810433

Brief Title

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

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mazor Robotics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

GO-LIF - Guided Oblique Lumbar Interbody Fusion

Other Intervention Name(s)

Mazor, SpineAssist, GO-LIF

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

Title

The number of procedures that were not completed, and the reasons and causality for non-completions.

Time Frame

Immediately post-op.

Secondary Outcome Measure Information:

Title

Time Frame

3, 6 and 12 months post-op.

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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: 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isador H Lieberman, MD, MBA, FRCSC

Organizational Affiliation

Texas Back Institute

Official's Role

Study Director

Facility Information:

Facility Name

Dep. Of Neurosurgery , Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Dep. Of Orthopedic Helios Rosmann Klinik

City

Breisach

ZIP/Postal Code

79206

Country

Germany

Facility Name

Dept. of Neurosurgery, Neurochirurgische Klinik Göttingen

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Dept. of Neurosurgery, Klinikum Nordstadt Hannover

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Dep. Of Neurosurgery Universitaetsklinikum Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Krankenhaus Munchen Schwabing

City

Munich

ZIP/Postal Code

80804

Country

Germany

Facility Name

Dep. Of Orthopedic Klinikum Grosshadern- LMU

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Dep. Of Neurosurgery Paracelsus kliniken

City

Munich

ZIP/Postal Code

81927

Country

Germany

Facility Name

Dept. of Orthopedics, Carmel Medical Center

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Dept. of Orthopedics Hadassah Medical Center - The Hebrew University

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

20819219

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs