1	Osteoporotic Compression Fractures Disease State Overview
2	OSTEOPOROSIS Osteoporosis is defined as a skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture. (NIH Consensus Conference on Osteoporosis, March 2000)
3	OSTEOPOROSIS A Public Health Problem Worldwide, 1 in 3 women and 1 in 8 men over 50 are affected by Osteoporosis¹ 44 Million People U.S. at Risk² 1.5 Million Fragility Fractures in U.S. per year ² 700,000 spine – 30% of fx occur in men³ 300,000 hip 250,000 wrist 300,000 other
4	OSTEOPOROTIC FRACTURES Economic Cost 2001 U.S. Hospital and Nursing Home Direct Expenditures > $17 Billion¹ - $47 Million Daily Vertebral Body Compression Fractures (VCFs) $1.5 Billion in Hospital Expenditures ³ 150,000 hospitalizations/year² (8 day average stay)⁴
5	VERTEBRAL COMPRESSION FRACTURE (VCF)
6	"Acute Event" Acute Event Sudden onset of back pain with little or no trauma Chronic Manifestations Loss of height¹ Spinal deformity¹ (“Dowager’s hump”) Protuberant abdomen¹
7	"Decrease in gait velocity¹" Decrease in gait velocity¹ Change in balance¹ Increased muscle fatigue¹ Increased risk of falls and additional fractures¹ Risk of VCF increases 5 fold after first VCF²
8	THE HUMAN COST Impaired Function Spinal deformity and pain impair function and decrease mobility ^1,2,3 Decreased activity leads to more bone loss³ Compressed abdomen decreases appetite^1,3 Sleep disorders develop^1,3
9	THE HUMAN COST Decreased Quality of Life Decreased activity Increased depression Lower self-esteem Increased anxiety Diminished social roles Increased dependence on others
10	THE HUMAN COST Mortality Women with 1 or more VCFs have 1.23 fold greater mortality¹ VCF 5 yr survival rate: Significantly worse than expected² Comparable to hip fx^2,3 Steadily declines compared to excess mortality in first 6 months after hip fx²
11	THE HUMAN COST Downward Spiral
12	Painful Osteoporotic Compression Fractures Treatment Objectives & Options
13	Orthopedic Fracture Care
14	Diagnosis Identify painful level Define fracture configuration Define fracture age Osteoporotic Fracture?
15	History and Physical Exam Has there been a recent event, prior to onset of pain? Does direct pressure on suspect vertebral bodies elicit pain? Pain findings on physical exam should be concordant with radiographic findings. Some patients will have multiple painful vertebral bodies.
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17	Deformity Progression
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19	VCF Treatment Objectives Restoration of anatomy¹ Early diagnosis and treatment for optimal outcomes² Special care for geriatric patients frail physical status and comorbidities² ¹Colton, CL. Ch. 1 in Skeletal Trauma. 1998²Brakoniecki et al. Ch. 7 in Skeletal Trauma. 1998
20	VCF Treatment Options Management for Pain Medical management Bed rest -- Exacerbates bone loss Narcotic analgesics -- May fail to relieve pain Braces -- May not provide long-term functional improvement Open Surgical Treatment Only in very rare cases of neurological deficit -- Invasive procedure with poor outcomes in osteopenic bone Vertebroplasty High risk of filler leaks^1,2 and complications ^3,4,5 Does not attempt fracture reduction – Freezes deformity
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24	New VCF Treatment Option Minimally Invasive Fracture Reduction
25	KyphX^®Inflatable Bone Tamp (IBT or Balloon)
26	Inflatable Bone Tamp Experience
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28	OR Set-Up Options
29	KyphX^®Inflatable Bone Tamp
30	Case Study
31	Case Study
32	Case Study
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