Treatment of Vertebral Compression Fractures with the Ascendx VCF Repair System M.Gillespy

Transcript

1. 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
3. Kyphoplasty ▪ Vertebral body balloon procedure followed by bone cement ▪ Painful acute and subacute osteoporotic VCF ▪ Pathologic VCF
4. 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
5. 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device to create cavity ▪ Introduce and inflate balloon ▪ Deliver cement around balloon ▪ Fill void while balloon is withdrawn
6. Cutting device
7. Cutting device
8. Balloon introduction
9. Balloon inflation
10. Cement introduction around balloon
11. Cement introduction around balloon
12. Remove balloon and fill cavity
13. 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.
14. 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
15. Visual Analog Scale ▪ Mean VAS score improved by 66mm at 12 months from 78.8 to 12.9 VAS
16. Oswestry Disability Index ▪ Mean ODI score improved by 45.2 points at 12 months from 62 to 16.8 ODI
17. 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
18. 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
19. Cement Extravasation ▪ Cement extravasation of 21.7% ▪ Determined by CT
20. Adjacent Level Fracture ! ▪ At 6 months 16.8%, ▪ At 12 months 20.1% 6 months 12 months 8 months
21. Complications ▪ One primary endpoint failure related to inadequate fluoroscopic visualization. ▪ One balloon malfunction related to protocol deviation
22. 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.
23. Merci