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SMART SPINALFUSION™
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WHAT ISSMART SPINAL FUSION™?
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FIRST-TIME-RIGHT
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SMART SPINAL FUSION™
FIRST TIME RIGHT
=
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WHAT ISFIRSTTIMERIGHT?
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Happy patients, pain free with excellent functionality
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with the intention to avoid revision surgery
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Understanding where spine surgery has its limits has been the strongest driver of our innovation
“
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non-fusionimplant migration and subsidencesuboptimal spinal alignmentimmunological reaction imaging artefacts
Major issues in spinal surgery
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SMART SPINAL IMPLANTS™
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3-D PRINTEDCELLULARTITANIUM®
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WHYSMART SPINAL IMPLANTS™?
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THEY ADD UP TO FIRST-TIME-RIGHT
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FIRST-TIME-RIGHT
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1. PRIMARY STABILITY
FIRST-TIME-RIGHT
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1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD
FIRST-TIME-RIGHT
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1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD3. SPINAL BALANCE
FIRST-TIME-RIGHT
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1. Primary stability
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Providing sufficient stability avoiding micro motion and allowing direct bony ingrowth
MACRO ROUGH SURFACE
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Shaped for smooth insertion, to adapt to endplate anatomy and allowing sagittal and coronal alignment
ANATOMICAL DESIGN
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2. Osteo active scaffold
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Micro-structure and nano-surface for natural bone ingrowth
CELLULAR TITANIUM®
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Size and shape of the pore do matter
MICRO-STRUCTURE
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diamond shape ideal size (~650 µm) 80% porosity maximal cell surface contact area proper space for vessels and bone cells
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Chemical and heat treatments increase total surface for cell attachment and potentially add to biological activity
NANO-SURFACE
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Close to cancellous bone - possibly avoiding stress shielding and implant subsidence
MODULUS OF ELASTICITY
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The osteo active scaffold is misleading the osteoblasts to start the bone healing process and bone maturation.
“
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3. Spinal balance
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Designed to help restore sagittal and coronal alignment
RESPECT FOR ANATOMYOF THE SPINE
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PRODUCT PORTFOLIO
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3 IMPORTANT CRITERIA FORSMART SPINAL FUSION™
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1. PRIMARY STABILITY2. OSTEO ACTIVE SCAFFOLD3. SPINAL BALANCE
FIRST-TIME-RIGHT
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AND IT SHOWS ...
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Pre-operative X-Ray and MRI
X-Ray Cervical
Direct operative 3 months postoperative
X-Ray EIT CervicalCage, Male 45 yrs
C5-C6, HNP/DDD
Excellent clinical improvement after 3 months, remaining after 1 yr follow up.
Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands
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1 year postoperative Flexion – Extension X-Rays
X-Ray Cervical
Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands
Note bone bridging anterior of the cage
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X-Ray Cervical double level
6 months Post-op ROM C5-C6 = 2.0°ROM C6-C7 = 2.9°with FXA dynamic X-Ray analysis
Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands
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X-Ray Lumbar PLIF
Without cage and rods With cage, without rods Full fixation and correction
Female 76 yr
360 spondylodese L4-L5
9 mm EIT PLIF cage
Correction of sagittal balance
Only short segment fusion
Courtesy of dr. Mark Havinga en dr. Dean Pakvis, OCON Hengelo, Netherlands
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X-Ray Lumbar PLIF
Courtesy of dr. Ulrich Quint, St. Marien-Hospital Hamm, Germany
Implant contours clearly visible under x-ray, nice fit with endplates.
Excellent restoration of the coronal and sagittal balance
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X-Ray Lumbar TLIF
X-Ray EIT TLIFcage, Female 54 yr
Degenerative scoliosis
L4-L5
EIT TLIF cage to restore lordosis segmental and Cobb angle in AP direction. Only short-term clinical results known, which are very good.
Post-operative improvement lordosis and neutral axis AP
Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands
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X-Ray Lumbar PLIF HL
PLIF High Lordotic implant: 26 x 9 mm 14 height and 12° lordosis
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
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MRI Cervical (with CIF implant)
Central canal and nerve roots can be evaluated
MRI appearance of EIT Cervical Cage at C5C6 with adjusted protocol T2 – spc – tra
Courtesy of dr. Jasper Wolfs, MCH The Hague, Netherlands
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MRI Lumbar (with PLIF implant)
Central canal and nerve roots can be evaluated
MRI appearance of EIT PLIF Cage at L5-S1
Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands
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MRI Lumbar (with PLIF HL implant)
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
Central canal and nerve roots can be evaluated
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CT 1 week postoperative AP view
CT 1 week postoperative lateral view
CT 3 months postoperative AP view
CT 3 months postoperative lateral view
CT Cervical
CT scan EIT Cervical Cage, Male 51 yr
C4-C5, C5-C6, HNP/DDD
Neck and arm-pain for several months
Clinical complaints improved immediately after the operation and are currently still resolved
Note densifying of trabecular structure in vertebral body from 3 months on, especially in the upper vertebrae.
Note thin white layers on both sides of the cage, indicating active bone-ingrowth in the EIT Cellular Titanium® structure.
Settings of (wide) window 2800-3200, and level 1000-1250 create optimal imaging to allow assessment of bone ingrowth in a porous titanium implant
Courtesy of Mr. Andrew Miles, St John God of Hope, Murdoch, Perth Australia
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CT Lumbar PLIF HL
PLIF High Lordotic implant: 26 x 9 mm 14 height and 12° lordosis
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
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CT Lumbar TLIF
No image distortion or scattering; implant bone contact well defined, postoperative radiolucent area’s (→) quickly filled up with bone(→).Bone-ingrowth into the cage and trabecular thickening in the direction of the force-transmission.
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
Double level TLIF direct postoperative and 6 months postoperative
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CT Lumbar TLIF
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
Single level TLIF 6 months postoperative
No image distortion or scattering; implant bone contact well defined; nice trabecular pattern in the direction of the force transmission
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CT Lumbar bone ingrowth TLIF
TLIF 6 months axial white dens area in porous titanium structureindicating bone ingrowth
TLIF 12 months axial increase in size of white dens area in porous titanium structure
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
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CT Lumbar bone ingrowth TLIF
Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
TLIF 6 months lateral white dens area in porous titanium structureindicating bone ingrowth
TLIF 12 months lateral increase in size of white dens area in porous titanium structure
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WHAT ARE THE BENEFITS OF FIRST-TIME-RIGHT?
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Quick elimination of pain, fast return to normal life and avoidance of re-operation
BETTER FOR PATIENTS
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One-time-right without a learning curve and more patient satisfaction
BETTER FOR SURGEONS
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Optimal imaging minimizing disturbing artefacts on MRI and CT scans
BETTER FOR CLINICAL EVALUATION
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Fast rehabilitation and quick return to normal activities
BETTER FOR SECOND LINE CARE
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Effective surgeries, positive press and strong position towards insurers
BETTER FOR HOSPITALS
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Cost-effective procedures when lowering number of revision surgery
BETTER FOR INSURERS
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Is accepting a failure rate useful
when it is not necessary?
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Will you take this next step in
fusion technology?
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SMART SPINALFUSION™
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FOR PEACE OF SPINE
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Thank you for your attention