1	Biologic Vertebral Reconstruction/Augmentation with Intravertebral Mesh and Bone Graft John C. Chiu, M.D., FRCS (US), D.Sc. Chief, Neurospine Surgery California Spine Institute Thousand Oaks, California, USA President, ISMISS/SICOT
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3	Introduction: In the US, approximately 700,000 vertebral compression fracture (VCF) secondary to osteoporosis per year High incident of motor vehicle and sports injury causing symptomatic post traumatic vertebral compression fracture Afflicted with secondary painful kyphosis, resulting spinal deformity High risk for spine, hip and wrist fractures, cardio pulmonary complications and physical disability from inactivity, including Chronic severe pain Decreased lung function Inactivity, severe anxiety and depression with 23% increase in mortality rate Subsequent adjacent vertebral VCF Lifetime risk of symptomatic VCF – osteoporotic: female 16%, male 5%
4	Lifetime Risk of Symptomatic Vertebral Compression Fracture (VCF) Increasing VCF osteoporosis among the coming baby boomers 5 years after diagnosis 61% survival rate VCF effecting 25% female over age of 50 VCF effecting 40% female over the age of 80 Of course there are always symptomatic, post traumatic vertebral compression fractures of various types among the active young and middle aged adults
5	Introduction: Vertebral augmentation, minimally invasive spinal technique (MIST) is indicated for painful VCF Vertebroplasty and kyphoplasty have provided excellent pain relief but with high incident of leakage of PMMA into spinal canal or vasculature, cardio pulmonary complications and adjacent vertebral fractures Since 2004 a polyethylene mesh sac (OptiMesh^®) with morcelized bone graft is used without above complications OptiMesh^® provides excellent pain relief and fewer technical risks, is a true biologic reconstruction and is osteo conductive and osteo inductive Can also be used as an intervertebral spacer and for intervertebral fusion/fixation
6	Introduction: Goal of vertebral augmentation (MIST): Provides stability and strengthens the spine Correction of vertebral body (VB) deformity Significant reduction of pain To improve quality of life To Improve ability to perform daily living activity To lower complication rate (e.g. hip fracture, pneumonia etc…)
7	Indications: Treatment criteria: Symptomatic osteoporotic or post-traumatic VCF Increased pain on upright and decreased on supine Pain unrelieved by analgesics and narcotics VCF due to osteoporosis, aggressive hemangiomas, metastatic disease, osteogenesis imperfecta, trauma or vertebral osteonecrosis Traumatic stable fracture Multiple VCF’s and kyphosis resulting in pulmonary compromise Positive 3 Legs of bar stool – symptoms, physical findings and testing (e.g. EMG, imaging and provocative discogram)
8	Contraindications: Painless asymptomatic stable VCF Massive “burst” vertebral fractures VCF responding to medical therapy Osteomyelitis of target vertebra Prophylactic treatment with no evidence of significant VCF Uncorrected bleeding or coagulation disorder
9	Contraindications: Unstable high risk patients Retro pulsed fragment causing spinal canal compromise of 20% or more Restless patient under IV conscious sedation Pain due to herniated disc, facet arthropathy, spinal stenosis or degenerative change and not due to VCF Pathological fracture with tumor extending into spinal canal
10	Vertebral Augmentation Implant Device - Intravertebral Mesh and Bone Graft Three-dimensional, multi-strand, polyester mesh/sac Allograft containment and reinforcement system inside the OptiMesh^® Ground corticocancellous or morcelized bone chips inside the OptiMesh^® device, hyper-dense graft pack Restoring height resulting in pain relief
11	Vertebral Augmentation with an Intravertebral Mesh and Bone Graft Granules flow like liquids when uncontained Granules act like solids when contained Granular packs are porous even in their most rigid state
12	Surgical Procedure: Anesthesia IV conscious sedation Neurophysiological monitoring Intravertebral implantation approach Parapedicular Minimally invasive Four basic surgical steps Portal placement Cavity creation Mesh insertion Mesh filling
13	Surgical Procedure: Prone on radiolucent table C-arm must be able to swing arc Fluoroscopy as “The 3^rd Eye” or “Eye of Wisdom” for confirmation of location of instruments
14	Guide Pin Placement: Parapedicular approach with the guide pin Under fluoroscopy guidance, the target position of “50/50 image” on AP and lateral view of vertebra Approximately 45° angle to contact the superior lateral quadrant of the pedicle at vertebral body junction Approximately 5-10cm from mid-line (thoracic 5-7cm and lumbar 8-10cm)
15	Guide Pin Trajectory: Guide pin projectory toward and beyond desired target position of “50/50 image” under fluoroscopy
16	Dilator/Access Portal: Dilator inserted over pin Access portal inserted over dilator and impacted into bone
17	Portal of Entry:
18	Drill: Begins channel creation Drilling depth provides sizing information
19	Cavity Creation: Cross referencing anticipated vertebral height and drilling depth determines mesh size; cavity enlarged with shaper Mesh size determines shaping amount and enables graft pack expansion, mesh pore distention and reduction Rotating knob on end of Shaper clockwise expands blades
20	Mesh Insertion: Mesh inserted with cannulated holder and an extender Apply gentle pressure to front of mesh with extender Insert till extender contacts distal side of cavity Release thumb pressure and push only on mesh holder
21	Mesh Filling: Initiated with diverted tubes Tubes rotated to direct bone within mesh Mallet strikes drive graft out of tube Impaction grafting enables intravertebral graft expansion, endplate lift, and strut formation
22	Disengage Mesh from Tip: Two part crimp is disassemble with special tool Remove mesh holder and “lock tube puller” together Mesh is released Instruments are removed and wound closed
23	Case Illustrations: Case I 51 year old male with severe thoracic pain from post-traumatic T4 vertebral compression fracture/kyphosis as the result of a boat accident Outpatient IV conscious sedation anesthesia for T4 OptiMesh^® VA Immediate postoperative pain relief Discharged from outpatient surgical facility in two hours
24	Surgical Procedure: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic thoracic T4 VCF
25	Case Illustrations: Case II 70 year old male with severe thoracolumbar pain on activity from T10 osteoporotic post-traumatic vertebral compression fracture Outpatient conscious sedation anesthesia for OptiMesh^® VA Immediate postoperative pain relief Discharged from outpatient surgical facility in two hours
26	Surgical Procedure: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic osteoporotic thoracic T10 VCF
27	Case III 31 year old male sales manager with intraticable severe lumbar pain on activity from post-traumatic L2 vertebral compression fracture Outpatient conscious sedation anesthesia for OptiMesh^® L2 vertebral augmentation Immediate postoperative pain relief Discharged from outpatient surgical facility in two hours Fourth post operative day travel to Asia
28	Surgical Procedure: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic L2 VCF
29	Case IV 42 year old male road maintenance worker with Scheuermann's disease of the thoracic spine fell at work and suffered post-traumatic T-7 VCF Outpatient conscious sedation anesthesia for OptiMesh^® VA Immediate postoperative pain relief Discharged from outpatient surgical facility in two hours
30	Surgical Procedure: Percutaneous Vertebral Augmentation: With an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic thoracic T7 VCF
31	Case V 70 year old female manager with painful post-traumatic osteoporotic wedge compressive T7 fracture Outpatient conscious sedation anesthesia for OptiMesh^® vertebral augmentation Immediate significant postoperative pain relief and returned to work in three days
32	Surgical Procedure: Percutaneous Vertebral Augmentation: Minimally invasive treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic osteoporotic T7 VCF
33	Case VI – Intervertebral Spacer and Fixation In a 92 yo business man with severe low back and leg pain secondary to grade I degenerative spondylolisthesis L4-5, neural foraminal stenosis and central stenosis This out patient OptiMesh® MISS, effectively decompressed spinal stenosis (i.e. foraminal) and neural compression on the nerve root and spinal cord and stabilized the spine
34	Discussion and Comment: The author’s personal experience has been positive OptiMesh^® system provides excellent pain relief and biologic reconstruction of the VCF Satisfaction score (96%) and significant improved clinical outcome with visual analogue pain scale (VAS), Oswestry disability score/index (ODI), and pain diagram were achieved
35	Conclusion: Vertebral reconstruction using the polyethylene mesh sac (OptiMesh^®) system/bone graft provides a MIST, minimally invasive, efficacious and controlled delivery mechanism to stabilize and to treat painful osteoporotic, degenerative, and post traumatic VCF It can also be used as an intervertebral spacer and lumbar fixation/fusion, and for decompression of spinal lateral stenosis
36	Video demo on OptiMesh^® procedure