1	Vertebral Augmentation with an Intravertebral Mesh and Bone Graft for Vertebral Compression Fractures John C. Chiu, M.D., FRCS, D.Sc. Chief Neurospine Surgery California Spine Institute Thousand Oaks, California, USA
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3	Lifetime Risk of Symptomatic Vertebral Compression Fracture (VCF) - Osteoporosis
4	Lifetime Risk of Symptomatic Vertebral Compression Fracture (VCF) VCF Osteoporosis 5 years after diagnosis 61% survival rate VCF effecting 25% female over age of 50 VCF effecting 40% female over the age of 80
5	Introduction: Correction of vertebral body (VB) deformity Significant reduction of pain Improvement of quality of life To improve ability to perform daily living activity Lower complication rate (e.g. hip fracture, pneumonia etc…
6	Introduction: In the united states, approximately 700,000 patients per year are afflicted by vertebral compression fracture (VCF) secondary to osteoporosis Secondary painful kyphosis, resulting spinal deformity from VCF High risk for hip fracture, cardiotoxicity, cardio pulmonary complications and physical disability from inactivity Other potential consequences: Chronic severe pain Decreased lung function Inactivity, severe anxiety and depression with 23% increase in mortality rate Subsequent adjacent vertebral VCF
7	Introduction: Vertebral augmentation is indicated for painful VCF Vertebroplasty and kyphoplasty have provided excellent pain relief for VCF – but with fairly high incident of complication i.e. leakage of PMMA into spinal canal or vasculature, cardio pulmonary complications and subsequent adjacent vertebral fractures Since 2004 a polyethylene mesh sac (OptiMesh^®) with morcelized bone graft is used for VCF treatment without above complications and is a true biologic vertebral reconstruction OptiMesh^® provides excellent pain relief and fewer technical risks and is osteo conductive and osteo inductive
8	Indications: Treatment criteria for percutaneous vertebral augmentation with polyethylene mesh sac are: Radiographic evidence of osteoporotic or post-traumatic compression fracture with severe pain localized to the fracture level Intractable pain in a focal band like radiation that is worse with weight bearing and is relieved with rest or in a recumbent position Intractable pain unrelieved by analgesics and narcotics. Compression fracture of vertebra due to osteoporosis, aggressive hemangiomas, metastatic disease, osteogenesis imperfecta, trauma or vertebral osteonecrosis Traumatic fracture of chronic type with non-union of fracture fragments Pre-surgical stabilization of partially compressed vertebral body or internal stabilization of unstable traumatic fracture Patient with multiple compression fractures, and kyphosis would result in pulmonary compromise
9	Contraindications: Absolute contra-indication in the following situations: Patient with painless asymptomatic stable VB compression fracture Massive “burst” osteoporotic or non osteoporotic fractures Patient with fracture that is clearly responding to medical therapy Osteomyelitis of target vertebra Prophylactic treatment with no evidence of fracture Uncorrected bleeding or coagulation disorder
10	Contraindications: Relative contra-indication in the following situations: Medically high risk patients, not stabilized. Retropulsed fragment causing spinal canal compromise of 20% or more Restless patient, unable to lie prone for the entire procedure 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
11	OptiMesh®Technology Three-dimensional, multi-strand, polyester mesh Allograft containment and reinforcement system inside the OptiMesh^® Specially ground corticocancellous or morcelized bone chips inside of the OptiMesh^® device creating hyper-dense graft pack For restoring height resulting in pain relief
12	Granular Mechanics Granules flow like liquids when uncontained Granules act like solids when contained Granular packs are porous even in their most rigid state
13	Surgical Procedure: Anesthesia most frequently performed under IV conscious sedation and at times general anesthesia
14	Surgical Procedure: Instruments and Preparation: Portal of entry: As described for thoracic and lumbar procedure, four finger breath from midline and two finger breath above the pedicle of the treated vertebra Vertebral augmentation OptiMesh^® device
15	Patient Position and Fluoroscopy Positioning: In a prone position as for the thoracolumbar surgery with fluoroscopy Prone on radiolucent table C-arm must be able to swing arc
16	Procedure Steps:
17	“Bullseye” Frame Attaches to table rails caudal to implant level To secure and guide the working channel (access portal)
18	Guide Pin Placement Under fluoroscopy guidance the desired target position of “50/50 image” on AP and lateral view of the spinal vertebra, via parapedicular approach with the guide pin Approximately 5-10cm from mid-line (thoracic 5-7cm and lumbar 8-10cm) Approximately 45° angle to contact the superior lateral quadrant of the pedicle and vertebral body junction
19	Guide Pin Trajectory Guide pin projectory toward and beyond desired target position of “50/50 image” (red dot) under fluoroscopy
20	Dilator/Access Portal Dilator inserted over pin Access portal inserted over dilator and impacted into bone
21	Secure “Bullseye” frame to Access Portal - Fixation Holds (fixation) trajectory Dissipates impaction force to table
22	Drill Begins cavity creation Provides information on sizing
23	Size and Shape Mesh size based on anticipated vertebral height, drill depth, and shaped cavity created Each size has a recommended cavity created by shaper to insure good radial compaction and mesh pore distension
24	Insert Mesh
25	Filling Mesh Initiated with diverted tubes Direct morcelized bone flow into the mesh/sac
26	Disengage Mesh from Tip Two part crimp is disassemble with special tool Mesh is released Instruments are removed and wound closed
27	Vertebral Augmentation Procedure illustration step by step
28	Step 1 Insert guide pin Dilator placed over pin
29	Step 2 Access portal over dilator Dilator and guide pin removed Drill initiates cavity creation
30	Step 3 Cavity enlarged with Shaper
31	Step 4 Insert OptiMesh^® implant
32	Step 5 OptiMesh^® filled with bone graft
33	Step 6 OptiMesh^® detached Instruments removed
34	Case Illustrations Case I 70 year old male with severe thoracolumbar pain on activity from T10 osteoporotic post-traumatic vertebral compression fracture Outpatient conscious sedation anesthesia for OptiMesh^® vertebral augmentation Immediate postoperative pain relief Discharged from outpatient surgical facility in two hours
35	Surgical Procedure/Technique: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic osteoporotic thoracic T10 vertebral compression fracture (VCF)
36	Case Illustrations Case II 72 year old female with severe thoracolumbar pain from T12 post traumatic osteoporotic vertebral compression fracture Outpatient conscious sedation anesthesia for OptiMesh^® vertebral augmentation Significant postoperative pain relief Discharged from outpatient surgical facility in one hour
37	Surgical Procedure/Technique: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic osteoporotic thoracic T12 vertebral compression fracture (VCF)
38	Case Illustrations Case III 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
39	Surgical Procedure/Technique: Percutaneous Vertebral Augmentation: Minimally Invasive Treatment with an intravertebral mesh (OptiMesh^®) with morcelized allograft or bone graft for painful post traumatic osteoporotic thoracic T7 vertebral compression fracture (VCF)
40	Conclusion: Vertebral reconstruction using the polyethylene mesh sac (OptiMesh^®) system/bone graft provides a minimally invasive, efficaceous and controlled delivery mechanism to stabilize and treat painful osteoporotic, traumatic and neoplastic VCF OptiMesh^® system provides excellent pain relief and biologic reconstruction of the VCF Patient satisfaction and clinical outcome are achieved The author’s personal experience has been outstanding I hope you enjoyed this presentation In conclusion, a video demo of OptiMesh^®procedure is to follow
41	Video demo on OptiMesh^® procedure