Balloon Kyphoplasty and Compression Fractures of the Spine: Conclusion and References

Conclusion
Balloon kyphoplasty is an excellent option associated with a low complication rate for patients suffering from painful vertebral compression fractures due to primary and secondary osteoporosis. By achieving fracture stabilization and correction of spinal deformity, patients experience significant reduction in pain and improvement in mobility, thus reducing the number of days in bed and increasing overall quality of life. In the prospective multicenter U.S. study, patients were asked to rate their level of satisfaction with the outcome of their balloon kyphoplasty procedure on a scale of 1-20, where 1 was "completely dissatisfied" and 20 was "completely satisfied". The mean score at one week post-operatively was 17.5 (88%) and persisted throughout two year follow-up. The median score was 20 (100%), or "extremely satisfied," at all follow-up time points.(11)

Balloon kyphoplasty is performed primarily in the U.S. and Europe to date and has been used since 1998 to treat 220,000 fractures in 187,000 patients (Kyphon internal data). For more information about balloon kyphoplasty, please visit www.kyphon.com.

References
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2. Coumans JV, Reinhardt MK, Lieberman I (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg (Spine 1) 99:44-50

3. Dudeney S, Lieberman IH, Reinhardt M-K, et al. (2002) Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 20:2382-2387

4. Fourney DR, Schomer DF, Nader R, et al. (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg (Spine 1) 98:21-30

5. Garfin SR, Yuan HA, Reiley MA (2001) Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511-1515

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7. Gold DT and Silverman SL (2003) The Downward Spiral of Vertebral Osteoporosis: Consequences. AACME monograph, designated by Cedars-Sinai Medical Center.

8. Hallal J (1991) Back pain with postmenopausal osteoporosis and vertebral fractures. Geriatr Nurs 7:285-287

9. Hsiang J (2003) An unconventional indication for open kyphoplasty. Spine J 3:520-523

10. Kado DM, Browner WS, Palermo L, et al. (1999) Vertebral Body Fractures and Mortality in Older Women. Arch Intern Med 159

11. Komp M, Ruetten S, Godolias G (2004) Minimally invasive therapy for functionally unstable osteoporotic vertebral fracture by means of kyphoplasty: Prospective comparative study of 19 surgically and 17 conservatively treated patients. J Miner Stoffwechs 11 (Suppl 1):13-15

12. Kyphon U.S. Multicenter Prospective Single Arm Study. Data on file at Kyphon Inc.

13. Lane JM, Johnson CE, Khan SN, et al. (2002) Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am 33:431-438

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16. Lieberman IH, Reinhardt M-K (2003) Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop 415(Suppl):S176-S186

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18. Lyles KW, Gold DT, Shipp KM, Pieper CF, Martinez S, Mulhausen PL (1993) Association of osteoporotic vertebral body compression fractures with impaired functional status. Am J Med 94: 595-601

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20. Phillips FM, Ho E, Campbell-Hupp M, McNally T, Wetzel T, Gupta P (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28, 19: 2260-2267

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23. Schlaich C, Minne HW, Bruckner T, et al. (1998) Reduced Pulmonary Function in Patients with Spinal Osteoporotic Fractures. Osteoporosis Int'l 8:261-267

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26. Theodorou DJ, Theodorou SJ, Duncan T, Garfin SR, Wong W (2002) Percutaneous Balloon Kyphoplasty for the Correction of Spinal Deformity in Painful Vertebral Compression Fractures. J Clin Imaging 26:1-5

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29. Wong W, Reiley MA, Garfin SR (2000) Vertebroplasty / Kyphoplasty. J Women's Imaging 2(3)

KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus. KyphX® HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Kyphon is a registered trademark and HV-R and Ahead of the Curve are trademarks of Kyphon Inc. © 2004 Kyphon Inc. All rights reserved. 16000320-03

Kyphon Inc.
1221 Crossman Ave.
Sunnyvale, CA 94089
www.kyphon.com
Phone: 877-459-7466
Fax: 408-548-6502
email: customerservice@kyphon.com

As with any surgery, there are potential risks. Although balloon kyphoplasty is designed to minimize these risks as much as possible, there is a chance that complications could occur. Serious adverse events can occur including: myocardial infarction (heart attack), cerebrovascular accident (stroke), pulmonary embolism (cement leakage that migrates to the lungs), cardiac arrest (heart stops beating), paralysis or muscle weakness, death. Patients should consult with their doctor for a full discussion of risks.