References

Advancing the Treatment of Spine Fractures

  1. Silverman SL. The Clinical Consequences of Vertebral Compression Fracture, Bone. 1992;13 Suppl 2:S27-31.
  2. Gold D. The Clinical Impact of Vertebral Fractures. Bone. 1996;18:1855-1895.
  3. Schlaich C. Reduced Pulmonary Function in Patients with Spinal Osteoporotic Fractures. Osteoporosis Int 1998;8:261-267.
  4. Kado D, Browner W, et al. Vertebral Fractures and Mortality. Arch Inter Med. 1999;159:1215-1220.


Understanding Vertebral Compression Fractures

  1. Old JL, Calvert M. Vertebral Compression Fractures in the Elderly. Am Fam Physician. 2004;69(1):111-116.
  2. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. 2008.
  3. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007; 22:465-475.
  4. Medtronic, Inc. updated estimate from 700,000 spinal fractures estimated in 1985-89 study: Riggs BL, Melton LJ 3rd. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995;17 Suppl 5:S505-511 for demographics and incidence rate per Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007; 22:465-475.
  5. Kondo ML. Osteoporotic Vertebral Compression Fractures and Vertebral Augmentation. Semin Intervent Radiol. 2008;25(4):413-424.


Treatment Related Health Concerns

  1. Lindsay R, Pack S, and Li Z. Longitudinal progression of fracture prevalence through a population of postmenopausal women with osteoporosis. Osteoporos Int. 2005;16(3):306-312.
  2. Black DM, et al. Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res. 1999;14(5):821-828.
  3. van Schoor NM, Smit JH, Twisk JW, Lips P. Impact of vertebral deformities, osteoarthritis, and other chronic diseases on quality of life: a population-based study. Osteoporos Int. 2005;16(7):749-756.
  4. Sinaki M. Falls, fractures, and hip pads. Curr Osteoporos Rep. 2004;2(4):131-137.
  5. Sinaki M, Brey RH, Hughes CA, Larson DR, and Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int. 2005;16(8):1004-1010.
  6. Schlaich C, et al. Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int. 1998;8(3):261-267.
  7. Leech JA, Dulberg C, Kellie S, Pattee L, and Gay J. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis. 1990;141(1):68-71.
  8. Lyles KW, et al, Association of osteoporotic vertebral compression fractures with impaired functional status. Am J Med. 1993;94(6):595-601.
  9. Greendale GA, Barrett-Connor E, Ingles S, and Haile R. Late physical and functional effects of osteoporotic fracture in women: the Rancho Bernardo Study. J Am Geriatr Soc. 1995;43(9):955-961.
  10. Pluijm SM, Tromp AM, Smit JH, Deeg DJ, and Lips P. Consequences of vertebral deformities in older men and women. J Bone Miner Res. 2000;15(8):1564-1572.
  11. Fink HA, Ensrud KE, Nelson DB, et al. Disability after clinical fracture in postmenopausal women with low bone density: the fracture intervention trial (FIT). Osteoporos Int. 2003;14(1):69-76.
  12. Nevitt MC, Ettinger B, Black DM, et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998;128(10):793-800.
  13. Silverman SL. The clinical consequences of vertebral compression fracture. Bone. 1992;13 Suppl 2:S27-31.
  14. *†Gold DT, Silverman SL. The downward spiral of vertebral osteoporosis: consequences (Monograph). Cedars-Sinai Medical Center 2003.
  15. Silverman SL, et al. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum. 2001;44(11):2611-2619.
  16. Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, and Cummings SR. Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med. 1999;159(11):1215-1220.
  17. *Johnell O, Kanis JA, Oden A, et al. Fracture risk following an osteoporotic fracture. Osteoporos Int. 2004;15(3):175-179.
  18. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. Jama. 2001;285(3):320-323.
  19. Kado DM, Huang MH, Karlamangla AS, Barrett-Connor E, and Greendale GA. Hyperkyphotic posture predicts mortality in older community-dwelling men and women: a prospective study. J Am Geriatr Soc. 2004;52(10):1662-1667.
  20. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, and Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579
  21. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, and Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.
  22. Fischer CG, Vaccaro AR, Whang PG, Prasad SK, Angevine PD, Mulpuri K, Thomas KC, and Patel AA. Evidence-Based Recommendations for Spine Surgery. Spine, 2010;36(14):E897-E903.
  23. Society of Interventional Radiology. Society of Interventional Radiology Supports Treatment for Painful Spine Fractures: Patient Selection Key. January, 2010.
  24. Smith SJ, Vlahos A, and Sewall L. An Objection to the New England Journal of Medicine Vertebroplasty Articles. Can Assn of Rad Jour. 2010;61(2):121-122.
  25. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman J, Rastam J, Eastel R, Shabe P, Talmadge K, and Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024.
  26. Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, and Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-1092


Disclosure:
an asterisk (*) denotes that some/all of the authors are paid Kyphon consultants. A cross (†) indicates that research cited may have been funded partially, or in whole, by Kyphon Inc.

The Importance of Establishing Key Criteria

  1. Fisher, Carter G.  Evidence-based recommendations for Spine Surgery.  Spine, Volume 35, 2010.
  2. Society of Interventional Radiology. Society of Interventional Radiology supports treatment for painful spine fractures: Patient selection key.  January 19, 2010.
RF-TVA™ with the StabiliT® Vertebral Augmentation System
  1. Lador R, Dreiangel N, Ben-Galim PJ, and Hipp JA. A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J. 2010;10(12):1118-1127.
  2. Murphy K. Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures in The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue JJ, Guyer R, Johnson JP, Khoo LT, Hochschuler H, and Hochschuler SH. Elsevier. Pg 248-252.
  3. Elgeti F and Gebauer B. Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. J Mimer Stoffwechs. 2011;18 Suppl 1:S5-9.
  4. Licht AW and Kramer W. Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures ¬– a case report. J Miner Stoffwechs. 2011;18 Suppl 1:S26-28.
  5. Licht, AW and Kramer W. One-year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Eurospine 2011.
  6. Erdem E, Akdol S, Amole A, Fryar K, and Eberle R. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. ASSR 2011.
  7. Pflugmacher R, Bornemann R, Randau T, and Wirtz DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. GRIBOI 2011 – The 21st Interdisciplinary Research Conference On Injectable Osteoarticular Biomaterials and Bone Augmentation Procedures.


StabiliT® Vertebral Augmentation System

  1. Lador R, Dreiangel N, Ben-Galim PJ, and Hipp JA. A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J. 2010;10(12):1118-1127.
  2. DFINE international data score. Data on file.


The StabiliT® System In Action During RF-TVA™

  1. Lador R, Dreiangel N, Ben-Galim PJ, and Hipp JA. A pictorial classification atlas of cement extravasation with vertebral augmentation. Spine J. 2010;10(12):1118-1127.
  2. Georgy, B. Comparison between RF Kyphoplasty, balloon kyphoplasty and high viscosity vertebroplasty in treatment of spinal compression fracture.” The 2nd Joint Meeting of European Society of Neuroradiology (ESNR) & American Society of Spine Radiology (ASSR). 2011.
  3. Erdem, E. Radiofrequency Kyphoplasty (RFK) for the Treatment of Vertebral Compression Fractures As A Result of Multiple Myeloma. ASSR 2011.


RF-TVA™: Clinically Proven Results

  1. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in comparison to in Vertebroplasty (VP) A prospective evaluation. IOF WCO-ECCEO10 2010.
  2. Licht, AW and Kramer W. One-year observation study upon a new augmentation procedure
  3. (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Eurospine 2011.
  4. Bornemann R, Hanna M, Kabir K, Goost H, Wirtz C, Pflugmacher R.   Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures.  European Spine Journal DOI: 10.1007/s00586-012-2148-8 Online First™ Springer-Verlag 2012
  5. Pflugmacher R, Bornemann R, Koch E, Randau T, Muller-Broich J, Lehmann U, Weber O, Wirtz C, Kabir K. .  Comparison of Clinical and Radiological Data in the Treatment of Patients with Osteoporotic Vertebral Compression Fractures Using Radiofrequency Kyphoplasty or Balloon Kyphoplasty und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn. Z Orthop Unfall 2012;150:56-61
  6. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in treatment of osteolytic vertebral fractures. IOF WCO-ECCEO10 2010.
  7. Sewall L, Smith S, and Vlahos A. Clinical Evaluation of Percutaneous Vertebral Augmentation Procedures using Radiofrequency Kyphoplasty in Treatment of 69 Vertebral Compression Fractures. ASBMR 2010.
  8. Erdem, E. Radiofrequency Kyphoplasty (RFK) for the Treatment of Vertebral Compression Fractures As A Result of Multiple Myeloma. ASSR 2011.


RF-TVA™ FAQ

  1. Silverman SL. The Clinical Consequences of Vertebral Compression Fracture, Bone. 1992;13 Suppl 2:S27-31.
  2. Gold D. The Clinical Impact of Vertebral Fractures. Bone. 1996;18:1855-1895.
  3. Schlaich C. Reduced Pulmonary Function in Patients with Spinal Osteoporotic Fractures. Osteoporosis Int 1998;8:261-267.
  4. Kado D, Browner W, et al. Vertebral Fractures and Mortality. Arch Inter Med. 1999;159:1215-1220.
  5. Murphy K. Radiofrequency Kyphoplasty: A Novel Approach to Minimally Invasive Treatment of Vertebral Compression Fractures in The Comprehensive Treatment of the Aging Spine: Minimally Invasive and Advanced Techniques edited by Yue JJ, Guyer R, Johnson JP, Khoo LT, Hochschuler H, and Hochschuler SH. Elsevier. Pg 248-252.
  6. Elgeti F and Gebauer B. Radiofrequency Kyphoplasty for the Treatment of Osteoporotic and Neoplastic Vertebral Body Fractures: Preliminary Experience and Clinical Results after 6 Months. J Mimer Stoffwechs. 2011;18 Suppl 1:S5-9.
  7. Licht A and Kramer W. Radiofrequency-Kyphoplasty in the Treatment of Vertebral Body Compression Fractures. Eurospine 2010.
  8. Pflugmacher R, Randau T, Kabir K, and Wirtz DC. Radiofrequency (RF) Kyphoplasty in treatment of osteolytic vertebral fractures. IOF 2010.
  9. Miko L, Szikora I, Grohs J, and Murphy K. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures. SIR 2009.
  10. Sewall L, Smith S, and Vlahos A. Clinical Evaluation of Percutaneous Vertebral Augmentation Procedures using Radiofrequency Kyphoplasty in Treatment of 69 Vertebral Compression Fractures. ASBMR 2010.
  11. Pflugmacher R, Bornemann R, Randau T, and Wirtz DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. IOF 2010.
  12. Heck P and Bayer-Helms H. Case report: Treatment by radiofrequency kyphoplasty of an 85-year-old woman with traumatic osteoporotic fracture of the first lumbar vertebra. J Miner Stoffwechs. 2011;18 Suppl 1:S29-31.
  13. Schekelmann R. Radiofrequency kyphoplasty – a case report on multiple osteoporotic sintering of the lumbar spine. J Miner Stoffwechs. 2011;18 Suppl 1:S32-34.
  14. Licht AW and Kramer W. Radiofrequency kyphoplasty: a new method for the treatment of osteoporotic vertebral body compression fractures ¬– a case report. J Miner Stoffwechs. 2011;18 Suppl 1:S26-28.
  15. Drees P, Kafchitsas K, Mattyasovszky S, Juri S, and Breijawi N. Radiofrequency Kyphoplasty - An Innovative Method of Treating Osteoporotic Vertebral Body Compression Fractures. J Miner Stoffwechs. 2011;18 Suppl 1:S13-17.
  16. Licht, AW and Kramer W. One-year observation study upon a new augmentation procedure (Radiofrequency-Kyphoplasty) in the treatment of vertebral body compression fractures. Eurospine 2011.
  17. Erdem E, Akdol S, Amole A, Fryar K, and Eberle R. Initial Clinical Experience with Radio-Frequency Based Vertebral Augmentation in Treatment of Vertebral Compression Fractures As a Result of Multiple Myeloma. ASSR 2011.
  18. Pflugmacher, R, Bornemann, R, Randau, T, and Wirtz, DC. Comparison of clinical and radiological data in treatment of patients with osteoporotic vertebral compression fractures with radiofrequency kyphoplasty or balloon kyphoplasty. GRIBOI 2011 – The 21st Interdisciplinary Research Conference On Injectable Osteoarticular Biomaterials and Bone Augmentation Procedures.