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STALIF  Single Incision 360 o TM Pablo Pazmiño, MD Beverly Hills, CA
Lumbar Fusion Primary   Aims of Treatment Elimination of pain provocation Removal of pain generator Prevent movement through anterior column stabilization Fusion of motion segment Restoration of sagittal balance Minimize morbidity Preserve Muscle Function
Interbody Fusion Creating the Right Environment Wide disc clearance removal of all nuclear material Provides broad surface for graft contact Preparation of endplates preserve load-bearing surfaces good cancellous graft contact exposure Load-sharing (Wolfe’s Law) These two techniques help facilitate load sharing and contribute to overall spinal stability
Ideal Device Greatest cross-sectional area for Stabilization / Bony Pillar Rigid segmental fixation Reduction of patient morbidity Ease of device insertion
PLIF/TLIF Approaches Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preservation Yes Yes Potentially ? ? Achieved
MIS PLIF/TLIF
The Working Window The TLIF requires resection of the facet which destabilizes but enables decompression. Variances in approach and soft tissue retraction.
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 In conjunction with A/P Reconstruction Still causes posterior muscle disruption Function as tension band  only Can not provide surface area for fusion
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 Graft containment Stable fixation of motion segment Resistance to axial, torsional and bending movements Eliminate the need for posterior fixation Restoration of disc height Restoration of lordosis Radiolucency MRI compatibility Allow for large graft area
Bone Graft Volume 2.8cc  11mm ht, 8 degree, 25 A/P, 36 Width 5.9cc  17mm ht, 12 degree, 29 A/P, 45 Width
Reminiscent of Humeral  Plating Systems
Screw Angulation and Pullout The convergent screw pattern of STALIF disperse the forces over the mass of the bone that is in between the screws in addition to the surface area of the screw threads. This applies forces throughout the entire mass of bone – not just the bone around the threads. In a convergent screw pattern rotational forces are applied to the mass of bone behind the screw as well as the threads. Axial screw pullout strength for the STALIF in Cancellous bone is 1249N for 5.5mm Diameter screw/ 1310N for 6.5mm Diameter Screws  (Parry, 2001)
Screw Pullout Screw backout associated with bending while loads placed transverse to the long axis of the screw (Chapman, J Bio Eng 96) Convergence of the screws as well creates a compound angle Their trajectory towards the VB center tends to reduce the transverse bending moment  No reported screw pullout in 15 years
STALIF ™ VBR Different Philosophy Prior Strict mid-line implant placement with other devices (L7, Femoral Ring, Carbon Fiber Cage, etc…) STALIF wide footprint resting on the apophyseal ring reduces subsidence Allows for complete disc removal  Laterally and down to PLL Posterolateral corners as well Posterior osteophyte removal Endplate preservation PEEK Optima Load-Sharing Biomaterial
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 “ Multidirectional Flexibility Properties of the STALIF Device versus Circumferential Spinal Arthrodesis: An In-Vitro Calf Spine Model” Andy Cappuccino MD Bryan Cunningham MSc. Paul C. McAfee MD Study Dates 12/21/05-3/16/06 Orthopedics Biomechanics Lab Baltimore , Md
Study Objectives Compare segmental flexibility properties of the STALIF TT VBR versus anterior stand alone cages and circumferential arthrodesis 2.  Quantify and compare the load at failure under destructive loading conditions
MATERIALS AND METHODS Specimen Preparation 28 fresh frozen calf lumbosacral  spines L3-sacrum utilized Randomized into four reconstruction groups (n=7 per group) Thawed to room temp. Potted in rectangular containers with 8 compression screws
Materials and Methods Plexiglass  motion detectors placed on the anterior aspect of L4, L5 and container base 2. Each marker equipped with 3 LED’s for detection by an optoelectronic motion measurement system(3020 Optotrak system)
FOUR STUDY GROUPS (L4-5)  1)  LT PEEK Cages Alone (n=7) Bilateral LT cages ( 19mm Dia. x 23mm Length ) (Medtronic Sofamor Danek, Inc.) were inserted from the anterior direction at the L4-L5 intervertebral level
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  STALIF  VBR (Paradigm BioDevices, Inc.Rockland, MA).  The number of fixation points was increased from two four to evaluate the effect of increasing fixation points
4)Anterior LT Peek cages and posterior Isola pedicle screw-rod instrumentation Bilateral LT cages were inserted from the anterior direction at the L4-L5 intervertebral level, followed by posterior ISOLA pedicle screw / rod instrumentation (Depuy-Spine, Inc.) to create a circumferential spinal arthrodesis.
STUDY GROUPS
MULTIDIRECTIONAL FLEXIBILITY TESTING Six pure non-destructive moments were applied to ensure multidirectionality Axial rotation (Y-axis +/- 6Nm) Flexion/extension (X-axis +/- 6Nm) Lateral bending (z-axis +/- 6Nm) Load applied to proximal specimen end Intact  Reconstructed specimen
All specimens tested on six degree of freedom spinal simulator All specimens followed by Optotrak motion analysis All specimens underwent continuous irrigation with 0.9% NaCl solution during testing MULTIDIRECTIONAL FLEXIBILITY TESTING
TESTING SEQUENCE OF  SPINAL CONSTRUCTS Intact spine Reconstructed Specimen Destructive Extension load to failure
DESTRUCTIVE TESTING Extension moment applied using an MTS858 system Rate of 5 degrees per second to quantify peak moment at failure Specimen/device failure was indicated by a significant decrease (approx. 30%) in applied moment as indicated on real time load-displacement tracings
DATA AND STATISTICAL ANALYSIS ROM calculated as the sum of the neutral and elastic zones (NZ + EZ = ROM) and represents the peak total range of motion at the third loading cycle Analysis conducted within the 3 dimensional conceptual frame work of Panjabi Statistical analysis includes a one way analysis of variance (ANOVA) to compare differences within groups and a Student –Newman-Keuls test to compare differences across treatment groups P < 0.05 was considered statistically significant
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 Fracture/ripping of residual annulus at operative level
FAILURE – LT Cage + Pyramid Fracture of the vertebral endplate at the operative level  Usually at the single screw site
LT cage + Pedicle Screw Failure Failure was similar to LT cages alone with tearing through the residual annulus  Screw cutout through the vertebral endplate at the operative level
STALIF OUTCOME Fracture of the vertebral endplate at the operative level. In all cases a trapezoidal mass of bone dislodged between the triangulated screws
Clinical Experience Several Peer-Reviewed Studies Multi-Center Safety & Efficacy (IMAST ’07) Clinical Study (Journal of Spinal Disorders ’01) Biomechanical Comparison (IMAST ’06) ProDisk Case Study (Spine 2005)
Safety and Efficacy Questions Answered What is the fusion rate with STALIF? Did the construct do what we wanted it to? Did it fall apart? What device complications were seen?
Performance & Safety of STALIF-  A Multi-Center Study 115 Contiguous Patients reviewed from nine (9) U.S. Centers Minimum of 1 year Follow-up 95% Fusion Rate 0 Pseudoarthroses No Broken Devices No Screw Dislodgements Presented at IMAST ‘07
Advantages of STALIF Shorter operation time Less anaesthetic risk Single procedure
Advantages of STALIF Reduced blood loss Posterior muscles preserved Reduced post-op pain Quicker recovery Shorter hospital stay Improved functional restoration
Long-term Restoration of Function and Reduction of Pain with movement Goal of STALIF Elimination of pain provocation Removal of pain generator Reduction of painful movement Fusion of motion segment Restoration of sagittal balance Minimize morbidity Preserve muscle function
End Plate Preparation Encourage a wide exposure Extensive disc removal and complete end plate preparation. Large anterior rectangular anulotomy Clear lateral posterior corners. Remove posterior osteophytes
Intra-operative trial placement and proper location
Permanent Implant Position
 
Case 1 56 yo police officer presents for a second opinion. 6-9/10 Low back pain  PMhx: Depression, Asthma PSx: Appendectomy.  Pexam: Pain with forward flexion past 70 degrees, pain with extension past 30 deg, SLR negative, 5/5 Strength throughout, tender to palpation over posterior lumbar spine/hardware prominent
 
Post Operative XRays
4 Month Post Op CT
Case 2 : Hybrid Scenario  3 Month Post Op CT
 
 
Outcomes Analysis of Hybrid Disc Arthroplasty   AbstractStudy Design.   A retrospective observational cohort study of consecutive patients with multiple level lumbar discogenic disease recalcitrant to conservative therapy. Objective.   Assess the efficacy and benefits of hybrid lumbar arthroplasty in the treatment of multiple level disc pathology.  Summary of Background Data.  There have been several biomechanical reports describing the single, multiple level and hybrid lumbar disc arthroplasty. However, few have studied the outcomes of hybrid arthroplasty for the surgical treatment of multiple level lumbar discogenic disease.  Introduction Fusion has long been considered the treatment of choice for severe pain arising from lumbar degenerative disc disease.  However, clinical and biomechanical research has demonstrated significant morbidity and long term clinical sequellae associated with spinal fusion constructs.  Recently, total disc arthroplasty has emerged as an alternative approach for dynamic stabilization of a painful intervertebral segment.  Both the Charite´ and ProDisc artificial disc replacements have been approved by the FDA as another treatment option for single level lumbar discogenic disc disease. They have demonstrated encouraging results throughout the initial short and mid term studies.  However, a considerable subset of patients demonstrate symptomatic multiple level lumbar discogenic disease.  The rationale behind arthroplasty in preserving adjacent level segments becomes more important in this group of patients given the larger cantilever forces at play with a potential longer fusion construct.  In efforts to preserve motion and limit force concentrations at the remaining lumbar segments hybrid disc arthroplasty is gaining momentum as a new treatment modality for patients with multilevel discogenic disease recalcitrant to conservative therapy. To our knowledge there are no clinical studies which evaluate the outcomes of patients with hybrid disc arthroplasty. The present study compares a subset of patients treated for multiple level disc pathology through their patient perceived outcomes, return to sport and work. Methods.   A total of 36 discs in 32 patients were reviewed. We performed hybrid disc arthroplasty using either the Charite or Prodisc-L prosthesis in concert with fusion constructs in 32 consecutive patients.  Outcome variables included radiographic fusion based on postoperative and follow up films, and clinical assessment using visual analog scale for back pain, the Oswestry disability instruments, return to sport, return to work, , and review of postoperative complications.  Results .  32 patients, 18 males (56.3%) and 14 females (43.8%) were treated with a hybrid construct.  Mean patient age was 48.69 years (range 30 to 69) and mean followup was 17.7 months.  The mean duration of back pain before surgery was 3.92 years.  All patients were available at each follow-up interval except one patient who was lost to followup.  Patients showed statistically significant improvement in ODI scores at all follow-up periods compared to baseline ( P  < 0.0001).  The mean ODI score at baseline was 58.97, which improved to a mean of 38.94 at recent followup.  Patients also showed statistically significant improvement in VAS scores at all follow-up periods compared to baseline ( P  < 0.0001).  The mean VAS score at baseline was 8.56, which improved to a mean of 3.69 at recent followup.  Improvement at each interval and overall was statistically significant (p<0.0001) using the Wilcoxon Rank Sum Test. Using the modified Stauffer-Coventry classification the mean outcome was 3.59 (range 2-4, SD 0.682 ). The mean interval from surgery to return to work for the 26 patients in employment was 3.6months or 111.63 days (range  7-351,SD 80.3).  The mean interval from surgery to return to sports was 5.2 months or 162.22 days (range 28-507, SD 106.5).  Return to sport, activities of daily living and return to work positively correlated to the patients’ perception of their surgical outcome .  Conclusions . Hybrid lumbar arthroplasty appears to be a safe and effective treatment for painful lumbar discogenic disease. The rate of improvement is rapid and sustained through 1.5 years.  This study observes outcomes and times to return to work and sport which may serve as a guide for patient education and post-operative expectation.
Dr Pazmiño: Spine Surgeon Dr. Wagmeister: Vascular Surgeon
Dr Lauryssen: Neurolgical Spine Dr Pazmiño: Orthopaedic Spine
Just prior to implantation  of a STALIF
Teamwork Best of both worlds for every case  Orthopaedic and Neuorsurgery
STALIF Inserted: Final View Prior to Closure
Problems that are avoided: Posterior muscle disruption reduced post-op pain quicker recovery shorter hospital stay better functional restoration Adjacent Segment Disease  (Hardware-related ) Facet Impingement Leading to ASD 30% Incidence at 2 yrs. (Banco, Jenis et al) 46% Incidence @ 7 yrs (Bridwell et al) Extended Surgical Time
Excellent Surgical Option Enabling Technology 15-year clinical heritage 4000+ Cases Completed in U.S. since 2/05 8000+ Cases Completed Worldwide Utilized by 350+ surgeons nationwide  Multiple surgical indications
Thank you for your time. If you know someone who could benefit from the STALIF® please refer them to our online website  or call for your appointment www.beverlyspine.com

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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. Lumbar Fusion Primary Aims of Treatment Elimination of pain provocation Removal of pain generator Prevent movement through anterior column stabilization Fusion of motion segment Restoration of sagittal balance Minimize morbidity Preserve Muscle Function
  • 3. Interbody Fusion Creating the Right Environment Wide disc clearance removal of all nuclear material Provides broad surface for graft contact Preparation of endplates preserve load-bearing surfaces good cancellous graft contact exposure Load-sharing (Wolfe’s Law) These two techniques help facilitate load sharing and contribute to overall spinal stability
  • 4. Ideal Device Greatest cross-sectional area for Stabilization / Bony Pillar Rigid segmental fixation Reduction of patient morbidity Ease of device insertion
  • 5. PLIF/TLIF Approaches Pain source removed Movement through disc prevented Sagittal balance restored Low associated morbidity Muscle function preservation Yes Yes Potentially ? ? Achieved
  • 7. The Working Window The TLIF requires resection of the facet which destabilizes but enables decompression. Variances in approach and soft tissue retraction.
  • 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. Percutaneous Pedicle Screw Instrumentation Source: Spine-Health.com In conjunction with A/P Reconstruction Still causes posterior muscle disruption Function as tension band only Can not provide surface area for fusion
  • 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. STALIF ™ VBR Design Rationale Graft containment Stable fixation of motion segment Resistance to axial, torsional and bending movements Eliminate the need for posterior fixation Restoration of disc height Restoration of lordosis Radiolucency MRI compatibility Allow for large graft area
  • 15. Bone Graft Volume 2.8cc 11mm ht, 8 degree, 25 A/P, 36 Width 5.9cc 17mm ht, 12 degree, 29 A/P, 45 Width
  • 16. Reminiscent of Humeral Plating Systems
  • 17. Screw Angulation and Pullout The convergent screw pattern of STALIF disperse the forces over the mass of the bone that is in between the screws in addition to the surface area of the screw threads. This applies forces throughout the entire mass of bone – not just the bone around the threads. In a convergent screw pattern rotational forces are applied to the mass of bone behind the screw as well as the threads. Axial screw pullout strength for the STALIF in Cancellous bone is 1249N for 5.5mm Diameter screw/ 1310N for 6.5mm Diameter Screws (Parry, 2001)
  • 18. Screw Pullout Screw backout associated with bending while loads placed transverse to the long axis of the screw (Chapman, J Bio Eng 96) Convergence of the screws as well creates a compound angle Their trajectory towards the VB center tends to reduce the transverse bending moment No reported screw pullout in 15 years
  • 19. STALIF ™ VBR Different Philosophy Prior Strict mid-line implant placement with other devices (L7, Femoral Ring, Carbon Fiber Cage, etc…) STALIF wide footprint resting on the apophyseal ring reduces subsidence Allows for complete disc removal Laterally and down to PLL Posterolateral corners as well Posterior osteophyte removal Endplate preservation PEEK Optima Load-Sharing Biomaterial
  • 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. BIOMECHANICAL TESTING “ Multidirectional Flexibility Properties of the STALIF Device versus Circumferential Spinal Arthrodesis: An In-Vitro Calf Spine Model” Andy Cappuccino MD Bryan Cunningham MSc. Paul C. McAfee MD Study Dates 12/21/05-3/16/06 Orthopedics Biomechanics Lab Baltimore , Md
  • 22. Study Objectives Compare segmental flexibility properties of the STALIF TT VBR versus anterior stand alone cages and circumferential arthrodesis 2. Quantify and compare the load at failure under destructive loading conditions
  • 23. MATERIALS AND METHODS Specimen Preparation 28 fresh frozen calf lumbosacral spines L3-sacrum utilized Randomized into four reconstruction groups (n=7 per group) Thawed to room temp. Potted in rectangular containers with 8 compression screws
  • 24. Materials and Methods Plexiglass motion detectors placed on the anterior aspect of L4, L5 and container base 2. Each marker equipped with 3 LED’s for detection by an optoelectronic motion measurement system(3020 Optotrak system)
  • 25. FOUR STUDY GROUPS (L4-5) 1) LT PEEK Cages Alone (n=7) Bilateral LT cages ( 19mm Dia. x 23mm Length ) (Medtronic Sofamor Danek, Inc.) were inserted from the anterior direction at the L4-L5 intervertebral level
  • 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
  • 27. 3) STALIF VBR STALIF VBR (Paradigm BioDevices, Inc.Rockland, MA). The number of fixation points was increased from two four to evaluate the effect of increasing fixation points
  • 28. 4)Anterior LT Peek cages and posterior Isola pedicle screw-rod instrumentation Bilateral LT cages were inserted from the anterior direction at the L4-L5 intervertebral level, followed by posterior ISOLA pedicle screw / rod instrumentation (Depuy-Spine, Inc.) to create a circumferential spinal arthrodesis.
  • 30. MULTIDIRECTIONAL FLEXIBILITY TESTING Six pure non-destructive moments were applied to ensure multidirectionality Axial rotation (Y-axis +/- 6Nm) Flexion/extension (X-axis +/- 6Nm) Lateral bending (z-axis +/- 6Nm) Load applied to proximal specimen end Intact Reconstructed specimen
  • 31. All specimens tested on six degree of freedom spinal simulator All specimens followed by Optotrak motion analysis All specimens underwent continuous irrigation with 0.9% NaCl solution during testing MULTIDIRECTIONAL FLEXIBILITY TESTING
  • 32. TESTING SEQUENCE OF SPINAL CONSTRUCTS Intact spine Reconstructed Specimen Destructive Extension load to failure
  • 33. DESTRUCTIVE TESTING Extension moment applied using an MTS858 system Rate of 5 degrees per second to quantify peak moment at failure Specimen/device failure was indicated by a significant decrease (approx. 30%) in applied moment as indicated on real time load-displacement tracings
  • 34. DATA AND STATISTICAL ANALYSIS ROM calculated as the sum of the neutral and elastic zones (NZ + EZ = ROM) and represents the peak total range of motion at the third loading cycle Analysis conducted within the 3 dimensional conceptual frame work of Panjabi Statistical analysis includes a one way analysis of variance (ANOVA) to compare differences within groups and a Student –Newman-Keuls test to compare differences across treatment groups P < 0.05 was considered statistically significant
  • 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
  • 40. FAILURE – LT Cages Alone Fracture/ripping of residual annulus at operative level
  • 41. FAILURE – LT Cage + Pyramid Fracture of the vertebral endplate at the operative level Usually at the single screw site
  • 42. LT cage + Pedicle Screw Failure Failure was similar to LT cages alone with tearing through the residual annulus Screw cutout through the vertebral endplate at the operative level
  • 43. STALIF OUTCOME Fracture of the vertebral endplate at the operative level. In all cases a trapezoidal mass of bone dislodged between the triangulated screws
  • 44. Clinical Experience Several Peer-Reviewed Studies Multi-Center Safety & Efficacy (IMAST ’07) Clinical Study (Journal of Spinal Disorders ’01) Biomechanical Comparison (IMAST ’06) ProDisk Case Study (Spine 2005)
  • 45. Safety and Efficacy Questions Answered What is the fusion rate with STALIF? Did the construct do what we wanted it to? Did it fall apart? What device complications were seen?
  • 46. Performance & Safety of STALIF- A Multi-Center Study 115 Contiguous Patients reviewed from nine (9) U.S. Centers Minimum of 1 year Follow-up 95% Fusion Rate 0 Pseudoarthroses No Broken Devices No Screw Dislodgements Presented at IMAST ‘07
  • 47. Advantages of STALIF Shorter operation time Less anaesthetic risk Single procedure
  • 48. Advantages of STALIF Reduced blood loss Posterior muscles preserved Reduced post-op pain Quicker recovery Shorter hospital stay Improved functional restoration
  • 49. Long-term Restoration of Function and Reduction of Pain with movement Goal of STALIF Elimination of pain provocation Removal of pain generator Reduction of painful movement Fusion of motion segment Restoration of sagittal balance Minimize morbidity Preserve muscle function
  • 50. End Plate Preparation Encourage a wide exposure Extensive disc removal and complete end plate preparation. Large anterior rectangular anulotomy Clear lateral posterior corners. Remove posterior osteophytes
  • 51. Intra-operative trial placement and proper location
  • 53.  
  • 54. Case 1 56 yo police officer presents for a second opinion. 6-9/10 Low back pain PMhx: Depression, Asthma PSx: Appendectomy. Pexam: Pain with forward flexion past 70 degrees, pain with extension past 30 deg, SLR negative, 5/5 Strength throughout, tender to palpation over posterior lumbar spine/hardware prominent
  • 55.  
  • 57. 4 Month Post Op CT
  • 58. Case 2 : Hybrid Scenario 3 Month Post Op CT
  • 59.  
  • 60.  
  • 61. Outcomes Analysis of Hybrid Disc Arthroplasty AbstractStudy Design. A retrospective observational cohort study of consecutive patients with multiple level lumbar discogenic disease recalcitrant to conservative therapy. Objective. Assess the efficacy and benefits of hybrid lumbar arthroplasty in the treatment of multiple level disc pathology. Summary of Background Data. There have been several biomechanical reports describing the single, multiple level and hybrid lumbar disc arthroplasty. However, few have studied the outcomes of hybrid arthroplasty for the surgical treatment of multiple level lumbar discogenic disease. Introduction Fusion has long been considered the treatment of choice for severe pain arising from lumbar degenerative disc disease. However, clinical and biomechanical research has demonstrated significant morbidity and long term clinical sequellae associated with spinal fusion constructs. Recently, total disc arthroplasty has emerged as an alternative approach for dynamic stabilization of a painful intervertebral segment. Both the Charite´ and ProDisc artificial disc replacements have been approved by the FDA as another treatment option for single level lumbar discogenic disc disease. They have demonstrated encouraging results throughout the initial short and mid term studies. However, a considerable subset of patients demonstrate symptomatic multiple level lumbar discogenic disease. The rationale behind arthroplasty in preserving adjacent level segments becomes more important in this group of patients given the larger cantilever forces at play with a potential longer fusion construct. In efforts to preserve motion and limit force concentrations at the remaining lumbar segments hybrid disc arthroplasty is gaining momentum as a new treatment modality for patients with multilevel discogenic disease recalcitrant to conservative therapy. To our knowledge there are no clinical studies which evaluate the outcomes of patients with hybrid disc arthroplasty. The present study compares a subset of patients treated for multiple level disc pathology through their patient perceived outcomes, return to sport and work. Methods. A total of 36 discs in 32 patients were reviewed. We performed hybrid disc arthroplasty using either the Charite or Prodisc-L prosthesis in concert with fusion constructs in 32 consecutive patients. Outcome variables included radiographic fusion based on postoperative and follow up films, and clinical assessment using visual analog scale for back pain, the Oswestry disability instruments, return to sport, return to work, , and review of postoperative complications. Results . 32 patients, 18 males (56.3%) and 14 females (43.8%) were treated with a hybrid construct. Mean patient age was 48.69 years (range 30 to 69) and mean followup was 17.7 months. The mean duration of back pain before surgery was 3.92 years. All patients were available at each follow-up interval except one patient who was lost to followup. Patients showed statistically significant improvement in ODI scores at all follow-up periods compared to baseline ( P < 0.0001). The mean ODI score at baseline was 58.97, which improved to a mean of 38.94 at recent followup. Patients also showed statistically significant improvement in VAS scores at all follow-up periods compared to baseline ( P < 0.0001). The mean VAS score at baseline was 8.56, which improved to a mean of 3.69 at recent followup. Improvement at each interval and overall was statistically significant (p<0.0001) using the Wilcoxon Rank Sum Test. Using the modified Stauffer-Coventry classification the mean outcome was 3.59 (range 2-4, SD 0.682 ). The mean interval from surgery to return to work for the 26 patients in employment was 3.6months or 111.63 days (range 7-351,SD 80.3). The mean interval from surgery to return to sports was 5.2 months or 162.22 days (range 28-507, SD 106.5). Return to sport, activities of daily living and return to work positively correlated to the patients’ perception of their surgical outcome . Conclusions . Hybrid lumbar arthroplasty appears to be a safe and effective treatment for painful lumbar discogenic disease. The rate of improvement is rapid and sustained through 1.5 years. This study observes outcomes and times to return to work and sport which may serve as a guide for patient education and post-operative expectation.
  • 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. Teamwork Best of both worlds for every case Orthopaedic and Neuorsurgery
  • 66. STALIF Inserted: Final View Prior to Closure
  • 67. Problems that are avoided: Posterior muscle disruption reduced post-op pain quicker recovery shorter hospital stay better functional restoration Adjacent Segment Disease (Hardware-related ) Facet Impingement Leading to ASD 30% Incidence at 2 yrs. (Banco, Jenis et al) 46% Incidence @ 7 yrs (Bridwell et al) Extended Surgical Time
  • 68. Excellent Surgical Option Enabling Technology 15-year clinical heritage 4000+ Cases Completed in U.S. since 2/05 8000+ Cases Completed Worldwide Utilized by 350+ surgeons nationwide Multiple surgical indications
  • 69. Thank you for your time. If you know someone who could benefit from the STALIF® please refer them to our online website or call for your appointment www.beverlyspine.com