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STALIF  Single Incision 360 o TM Pablo Pazmiño, MD Beverly Hills, CA
Lumbar Fusion Primary   Aims of Treatment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Interbody Fusion Creating the Right Environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Ideal Device ,[object Object],[object Object],[object Object],[object Object]
PLIF/TLIF Approaches ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Achieved
MIS PLIF/TLIF
The Working Window ,[object Object],[object Object]
The MIS Approach
The Reality
Anterior-Posterior (360 o ) Approach   Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preserved Yes Yes Yes ? ? Achieved
Percutaneous Pedicle Screw Instrumentation Source: Spine-Health.com ,[object Object],[object Object],[object Object],[object Object]
What about Cages &  Anterior Lumbar Plating?
Vascular Anatomy Bifurcation –  Variations ( high / low)   Ilio-lumbar vein –Often ligated to    access to L4/5  Pre-sacral vessels –Isolated /ligated    to access L5/S1 Anterior Plates may have the potential to Erode Great Vessels/DVT
STALIF ™ VBR  Design Rationale ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Bone Graft Volume ,[object Object],[object Object]
Reminiscent of Humeral  Plating Systems
Screw Angulation and Pullout ,[object Object],[object Object],[object Object]
Screw Pullout ,[object Object],[object Object],[object Object],[object Object]
STALIF ™ VBR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STALIF ™- Single Incision 360™ Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preserved Yes Yes Yes Yes Yes Achieved
BIOMECHANICAL TESTING ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Study Objectives ,[object Object],[object Object]
MATERIALS AND METHODS ,[object Object],[object Object],[object Object],[object Object],[object Object]
Materials and Methods ,[object Object],[object Object]
FOUR STUDY GROUPS (L4-5)  ,[object Object],[object Object]
2) LT Peek cages + anterior Pyramid plate with screws LT Cage + Pyramid Anterior Plate (n=7) The bilateral LT cages were augmented using the Pyramid Anterior Plate (Medtronic Sofamor Danek, Inc.), which was inserted anteriorly spanning the operative L4-L5 level.  Two screws were inserted at the inferior level and one superiorly
3) STALIF VBR  ,[object Object],[object Object]
4)Anterior LT Peek cages and posterior Isola pedicle screw-rod instrumentation ,[object Object]
STUDY GROUPS
MULTIDIRECTIONAL FLEXIBILITY TESTING ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],MULTIDIRECTIONAL FLEXIBILITY TESTING
TESTING SEQUENCE OF  SPINAL CONSTRUCTS ,[object Object],[object Object],[object Object]
DESTRUCTIVE TESTING ,[object Object],[object Object],[object Object]
DATA AND STATISTICAL ANALYSIS ,[object Object],[object Object],[object Object],[object Object]
Biomechanical Data
NON DESTRUCTIVE ROM AXIAL ROTATION Error bars represent one standard deviation and significance is indicated at p<0.05. Intact demonstrated more motion compared to LT Cages+ pedicle screws and STALIF groups (p<0.05).
LATERAL BENDING ROM : Z Axis .  No other comparisons between the six reconstruction groups were statistically significant (p>0.05) (One Way ANOVA: F=24.32, p=0.000)
FLEXION-EXTENSION ROM No S. differences were noted between STALIF and LTPS  construct (p>0.05) (One Way ANOVA: F=26.55, p=0.000)
EXTENSION LOAD TO FAILURE LT Cage combined with pedicle screws as producing the greatest mean moment at failure compared to the remaining treatments, however, was not statistically different from the other treatments (p>0.05
FAILURE – LT Cages Alone ,[object Object]
FAILURE – LT Cage + Pyramid ,[object Object],[object Object]
LT cage + Pedicle Screw Failure ,[object Object],[object Object]
STALIF OUTCOME ,[object Object]
Clinical Experience ,[object Object],[object Object],[object Object],[object Object],[object Object]
Safety and Efficacy Questions Answered ,[object Object],[object Object],[object Object],[object Object]
Performance & Safety of STALIF-  A Multi-Center Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Advantages of STALIF ,[object Object],[object Object],[object Object]
Advantages of STALIF ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Long-term Restoration of Function and Reduction of Pain with movement Goal of STALIF ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
End Plate Preparation ,[object Object],[object Object],[object Object],[object Object],[object Object]
Intra-operative trial placement and proper location
Permanent Implant Position
 
Case 1 ,[object Object],[object Object],[object Object],[object Object],[object Object]
 
Post Operative XRays
4 Month Post Op CT
Case 2 : Hybrid Scenario  3 Month Post Op CT
 
 
Outcomes Analysis of Hybrid Disc Arthroplasty   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dr Pazmiño: Spine Surgeon Dr. Wagmeister: Vascular Surgeon
Dr Lauryssen: Neurolgical Spine Dr Pazmiño: Orthopaedic Spine
Just prior to implantation  of a STALIF
Teamwork ,[object Object],[object Object]
STALIF Inserted: Final View Prior to Closure
Problems that are avoided: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]

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Lumbar Fusion : A New Anterior Only Option. The STALIF

  • 1. STALIF Single Incision 360 o TM Pablo Pazmiño, MD Beverly Hills, CA
  • 2.
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  • 10. Anterior-Posterior (360 o ) Approach Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preserved Yes Yes Yes ? ? Achieved
  • 11.
  • 12. What about Cages & Anterior Lumbar Plating?
  • 13. Vascular Anatomy Bifurcation – Variations ( high / low) Ilio-lumbar vein –Often ligated to access to L4/5 Pre-sacral vessels –Isolated /ligated to access L5/S1 Anterior Plates may have the potential to Erode Great Vessels/DVT
  • 14.
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  • 16. Reminiscent of Humeral Plating Systems
  • 17.
  • 18.
  • 19.
  • 20. STALIF ™- Single Incision 360™ Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preserved Yes Yes Yes Yes Yes Achieved
  • 21.
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  • 26. 2) LT Peek cages + anterior Pyramid plate with screws LT Cage + Pyramid Anterior Plate (n=7) The bilateral LT cages were augmented using the Pyramid Anterior Plate (Medtronic Sofamor Danek, Inc.), which was inserted anteriorly spanning the operative L4-L5 level. Two screws were inserted at the inferior level and one superiorly
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  • 36. NON DESTRUCTIVE ROM AXIAL ROTATION Error bars represent one standard deviation and significance is indicated at p<0.05. Intact demonstrated more motion compared to LT Cages+ pedicle screws and STALIF groups (p<0.05).
  • 37. LATERAL BENDING ROM : Z Axis . No other comparisons between the six reconstruction groups were statistically significant (p>0.05) (One Way ANOVA: F=24.32, p=0.000)
  • 38. FLEXION-EXTENSION ROM No S. differences were noted between STALIF and LTPS construct (p>0.05) (One Way ANOVA: F=26.55, p=0.000)
  • 39. EXTENSION LOAD TO FAILURE LT Cage combined with pedicle screws as producing the greatest mean moment at failure compared to the remaining treatments, however, was not statistically different from the other treatments (p>0.05
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  • 51. Intra-operative trial placement and proper location
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  • 57. 4 Month Post Op CT
  • 58. Case 2 : Hybrid Scenario 3 Month Post Op CT
  • 59.  
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  • 62. Dr Pazmiño: Spine Surgeon Dr. Wagmeister: Vascular Surgeon
  • 63. Dr Lauryssen: Neurolgical Spine Dr Pazmiño: Orthopaedic Spine
  • 64. Just prior to implantation of a STALIF
  • 65.
  • 66. STALIF Inserted: Final View Prior to Closure
  • 67.
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  • 69.