WHAT IS SMART SPINAL FUSION?
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1 SMART SPINAL FUSION
2 WHAT IS SMART SPINAL FUSION?
3 FIRST-TIME-RIGHT
4 SMART SPINAL FUSION = FIRST TIME RIGHT
5 WHAT IS FIRST TIME RIGHT?
6 Happy patients, pain free with excellent functionality
7 with the intention to avoid revision surgery
8 Understanding where spine surgery has its limits has been the strongest driver of our innovation
9 Major issues in spinal surgery non-fusion implant migration and subsidence suboptimal spinal alignment immunological reaction imaging artefacts
10 SMART SPINAL IMPLANTS
11 3-D PRINTED CELLULAR TITANIUM
12 WHY SMART SPINAL IMPLANTS?
13 THEY ADD UP TO FIRST-TIME-RIGHT
14 FIRST-TIME-RIGHT
15 1. PRIMARY STABILITY FIRST-TIME-RIGHT
16 1. PRIMARY STABILITY 2. OSTEO ACTIVE SCAFFOLD FIRST-TIME-RIGHT
17 1. PRIMARY STABILITY 2. OSTEO ACTIVE SCAFFOLD 3. SPINAL BALANCE FIRST-TIME-RIGHT
18 1. Primary stability
19 MACRO ROUGH SURFACE Providing sufficient stability avoiding micro motion and allowing direct bony ingrowth
20 ANATOMICAL DESIGN Shaped for smooth insertion, to adapt to endplate anatomy and allowing sagittal and coronal alignment
21 2. Osteo active scaffold
22 CELLULAR TITANIUM Micro-structure and nano-surface for natural bone ingrowth
23 MICRO-STRUCTURE Size and shape of the pore do matter
24 diamond shape ideal size (~650 µm) 80% porosity maximal cell surface contact area proper space for vessels and bone cells
25 NANO-SURFACE Chemical and heat treatments increase total surface for cell attachment and potentially add to biological activity
26 MODULUS OF ELASTICITY Close to cancellous bone - possibly avoiding stress shielding and implant subsidence
27 The osteo active scaffold is misleading the osteoblasts to start the bone healing process and bone maturation.
28 3. Spinal balance
29 RESPECT FOR ANATOMY OF THE SPINE Designed to help restore sagittal and coronal alignment
30 PRODUCT PORTFOLIO
31 3 IMPORTANT CRITERIA FOR SMART SPINAL FUSION
32 1. PRIMARY STABILITY 2. OSTEO ACTIVE SCAFFOLD 3. SPINAL BALANCE FIRST-TIME-RIGHT
33 AND IT SHOWS...
34 X-Ray Cervical X-Ray EIT Cervical Cage, Male 45 yrs C5-C6, HNP/DDD Excellent clinical improvement after 3 months, remaining after 1 yr follow up. Pre-operative X-Ray and MRI Direct operative 3 months postoperative Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands
35 X-Ray Cervical 1 year postoperative Flexion Extension X-Rays Note bone bridging anterior of the cage Courtesy of dr. Jasper Wolfs and dr. Mark Arts MCH The Hague, Netherlands
36 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
37 X-Ray Lumbar PLIF Female 76 yr 360 spondylodese L4-L5 9 mm EIT PLIF cage Correction of sagittal balance Only short segment fusion Without cage and rods With cage, without rods Full fixation and correction Courtesy of dr. Mark Havinga en dr. Dean Pakvis, OCON Hengelo, Netherlands
38 X-Ray Lumbar PLIF Implant contours clearly visible under x-ray, nice fit with endplates. Excellent restoration of the coronal and sagittal balance Courtesy of dr. Ulrich Quint, St. Marien-Hospital Hamm, Germany
39 X-Ray Lumbar TLIF Post-operative improvement lordosis and neutral axis AP X-Ray EIT TLIF cage, 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. Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands
40 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
41 MRI Cervical (with CIF implant) MRI appearance of EIT Cervical Cage at C5C6 with adjusted protocol T2 spc tra Central canal and nerve roots can be evaluated Courtesy of dr. Jasper Wolfs, MCH The Hague, Netherlands
42 MRI Lumbar (with PLIF implant) MRI appearance of EIT PLIF Cage at L5-S1 Central canal and nerve roots can be evaluated Courtesy of dr. Steven van Gaalen, Diakonessenhuis Utrecht, Netherlands
43 MRI Lumbar (with PLIF HL implant) Central canal and nerve roots can be evaluated Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
44 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 CT 1 week postoperative lateral view CT 3 months postoperative lateral view 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 , and level create optimal imaging to allow assessment of bone ingrowth in a porous titanium implant CT 1 week postoperative AP view CT 3 months postoperative AP view Courtesy of Mr. Andrew Miles, St John God of Hope, Murdoch, Perth Australia
45 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
46 CT Lumbar TLIF Double level TLIF direct postoperative and 6 months postoperative 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
47 CT Lumbar TLIF 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 Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
48 CT Lumbar bone ingrowth TLIF TLIF 6 months axial white dens area in porous titanium structure indicating 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
49 CT Lumbar bone ingrowth TLIF TLIF 6 months lateral white dens area in porous titanium structure indicating bone ingrowth TLIF 12 months lateral increase in size of white dens area in porous titanium structure Courtesy of dr. John Cunningham, Epworth Medical Centre Richmond Australia
50 WHAT ARE THE BENEFITS OF FIRST-TIME-RIGHT?
51 BETTER FOR PATIENTS Quick elimination of pain, fast return to normal life and avoidance of re-operation
52 BETTER FOR SURGEONS One-time-right without a learning curve and more patient satisfaction
53 BETTER FOR CLINICAL EVALUATION Optimal imaging minimizing disturbing artefacts on MRI and CT scans
54 BETTER FOR SECOND LINE CARE Fast rehabilitation and quick return to normal activities
55 BETTER FOR HOSPITALS Effective surgeries, positive press and strong position towards insurers
56 BETTER FOR INSURERS Cost-effective procedures when lowering number of revision surgery
57 Is accepting a failure rate useful when it is not necessary?
58 Will you take this next step in fusion technology?
59 SMART SPINAL FUSION
60 FOR PEACE OF SPINE
61 Thank you for your attention
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