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Treatment of Vertebral Compression Fractures wi...
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journeevertebro
November 03, 2013
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Treatment of Vertebral Compression Fractures with the Ascendx VCF Repair System M.Gillespy
journeevertebro
November 03, 2013
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Transcript
Treatment of Vertebral Compression Fractures with the Ascendx VCF Repair
System Mark C. Gillespy, M.D., F.A.B.O.S., F.A.A.O.S. Associate Professor, University of Florida Orthopaedic Clinic of Daytona Beach ! Paris February 10, 2012
None
Kyphoplasty ▪ Vertebral body balloon procedure followed by bone cement
▪ Painful acute and subacute osteoporotic VCF ▪ Pathologic VCF
Ascendx Balloon vs Traditional Balloon ▪ Traditional balloon is inflated
then removed before cement introduced ▪ Ascendx Balloon is inflated and cement delivered around inflated balloon Kyphx Ascendx
Ascendx Technique ▪ Single pedicle access ▪ Articulating cutting device
to create cavity ▪ Introduce and inflate balloon ▪ Deliver cement around balloon ▪ Fill void while balloon is withdrawn
Cutting device
Cutting device
Balloon introduction
Balloon inflation
Cement introduction around balloon
Cement introduction around balloon
Remove balloon and fill cavity
Ascendx IDE Study ▪ 60 subjects at 8 sites ▪
Primary Endpoint was acute procedural success ▪ VAS, ODI, SF-36, Adverse Events captured at baseline, post-op, 30 days, 3 months, 6 months and 12 months.
Ascendx IDE Study ▪ 60 patients enrolled ▪ 58 completed
primary endpoint (96.7%) ▪ 52 completed 6 months (86.7%) ▪ 49 completed 12 months (81.7%) ▪ 1 withdrew consent ▪ 5 expired of unrelated causes ▪ 5 lost to follow-up
Visual Analog Scale ▪ Mean VAS score improved by 66mm
at 12 months from 78.8 to 12.9 VAS
Oswestry Disability Index ▪ Mean ODI score improved by 45.2
points at 12 months from 62 to 16.8 ODI
SF-36 Physical Component ! ▪ Mean SF-36 PCS (physical) score
improved by 16.8 points at 12 months, from 25.6 to 42.4 SF-36 PCS
SF-36 Mental Component ▪ Mean SF-36 MCS (mental) score improved
by 13.0 points at 12 months, from 37.7 to 50.7 SF-36 MCS
Cement Extravasation ▪ Cement extravasation of 21.7% ▪ Determined by
CT
Adjacent Level Fracture ! ▪ At 6 months 16.8%, ▪
At 12 months 20.1% 6 months 12 months 8 months
Complications ▪ One primary endpoint failure related to inadequate fluoroscopic
visualization. ▪ One balloon malfunction related to protocol deviation
Summary ▪ The Ascendx Balloon unique design allows cement introduction
with balloon inflated. ▪ Acute procedural success in 58/60 patients. ▪ Low complication rate. ▪ VAS, ODI, SF-36 significant improvement . ▪ Cement extravasation (by CT) equal or better than literature. ▪ Adjacent level fracture similar to literature.
Merci