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

Lower Back Pain Clinical Trial

Official title:

A Clinical Safety and Feasibility Study of the GO-LIF® Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810433
• Other study ID #: CLN-102
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: February 6, 2014
• Start date: February 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2014
• Source: Mazor Robotics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00786955

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain
• Lower Back Pain

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Mazor Robotics

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	The number of procedures that were not completed, and the reasons and causality for non-completions.		Immediately post-op.	No
Secondary	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.	No
Secondary	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	No