Abstract
The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs). This study is based on a systematic review of the literature (until October 2004) and meta-analysis of clinical studies assessing the efficacy and safety of BK in the treatment of VCFs. Estimates of effect were based on a random effects model. Meta-regression analyses were carried out where required. A total of 26 studies met the inclusion criteria. Although studies displayed considerable methodological limitations, the results of the clinical series indicate significant improvements in pain intensity, vertebral height, sagittal alignment, functional capacity, and quality of life. Compared with conventional medical management, BK afforded significant improvement in pain intensity and mobility. Likewise, a significant reduction was observed in vertebral collapse, kyphotic deformity, the development of new vertebral fractures, and hospital stay. Compared with vertebroplasty, the technique reduced the loss of height and the degree of kyphotic deformity, and afforded a significantly lower leakage rate—with no differences in relation to other variables. Regarding adverse effects, leakage affected 7% of all levels treated, while complications were recorded in 2% of the patients, and new vertebral fractures in 16%. The available evidence suggests that BK can be effective and safe in application to VCFs. However, existing studies evince substantial methodological limitations and relatively short follow-up periods. Better clinical research is required to determine the capacity of BK to avoid the functional and physiological sequelae of VCFs and to define the true role of the technique among the existing therapeutic options.
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References
Australian Safety and Efficacy Register of New Interventional Procedures—Surgical. ASERNIP-S (2003) Percutaneous Vertebroplasty. New and Emerging Techniques-Surgical
Belkoff SM, Mathis JM, Fenton DC, Scribner RM, Reiley ME, Talmadge K (2001) An ex vivo biomechanical evaluation of an inflatable bone tamp used in the treatment of compression fracture. Spine 26:151–156
Benson K, Hartz AJ (2000) A comparison of observational studies and randomized controlled trials. N Engl J Med 342:1878–1886
Berlemann U, Franz T, Orler R, Heini PF (2004) Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective non-randomized study. Eur Spine J 13:496–501
Black N (1996) Why we need observational studies to evaluate the effectiveness of health care. BMJ 312:1215–1218
Canadian Coordinating Office for Health Technologies Assessment (CCOHTA) (2002). Percutaneous vertebroplasty: a bone cement procedure for spinal pain relief. Issues Emerg Health Technol 31:1–4
Clarke M, Oxman AD (2003) Cochrane reviewer’s handbook 4.1.6 [updated January 2003]. The Cochrane library, number 1, Update Software, Oxford
Cortet B, Roches E, Logier R, Houvenagel E, Gaydier-Souquieres G, Puisieux F, Delcambre B (2002) Evaluation of spinal curvatures after a recent osteoporotic vertebral fracture. Joint Bone Spine 69:201–208
Coumans JVCE, Reinhardt MK, Lieberman IH (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg 99:44–50
Crandall D, Slaughter D, Hankins PJ, Moore C, Jerman J (2004) Acute versus chronic vertebral compression fractures treated with kyphoplasty: early results. Spine J 4:418–424
Fourney DR, Schomer DF, Nader R, Chlan-Fourney J, Suki D, Ahrar K, Rhines LD, Gokaslan ZL (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg 98:21–30
Fribourg D, Tang C, Parveen S, Delamartier R (2004) Incidence of subsequent vertebral fracture after Kyphoplasty. Spine 29:2270–2276
Gaitanis IN, Hadjipavlou AG, Katonis PG, Tzermiadianos MN, Pasku DS, Patwardhan A (2005) Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures (Epub 2004 October 8). Eur Spine J 14:250–260
Garfin SR, Yuan HA, Reiley MA (2001) New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511–1515
Garfin SR (2003) Kyphon’s postmarketing study: Vertebral Body Compression Fracture Patient Registry. Final report. Kyphon Inc
Gavaghan DJ, Moore RA, McQuay HJ (2000) An evaluation of homogeneity tests in meta-analyses in pain using simulations of individual patient data. Pain 85:415–424
Grados F, Depriester C, Cayrolle G, Hardy N, Deramond H, Fardellone P (2000) Long-term observations of vertebral osteoporotic fractures treated by percutaneous vertebroplasty. Rheumatology 39:1410–1414
Grohs JG, Krepler P (2004) Minimal invasive stabilization of osteoporotic vertebral compression fractures. Methods and Preinterventional Diagnostics Radiologe 44:254–259
Hardouin P, Fayada P, Leclet H, Chopin D (2002) Kyphoplasty. Joint Bone Spine 69:256–261
Harrop JS, Prpa B, Reinhardt MK, Lieberman I (2004) Primary and secondary osteoporosis’ incidence of subsequent vertebral compression fractures after kyphoplasty. Spine 29:2120–2125
Heini PF, Orler R (2004) Kyphoplasty for treatment of osteoporotic vertebral fractures. Eur Spine J 13:184–192
Hillmeier J, Meeder PJ, Noldge G, Kock HJ, Da Fonseca K, Kasperk HC (2004) Augmentation von Wirbelkorperfrakturen mit einem neuen Calciumphosphat-Zement nach Ballon-Kyphoplastie. Orthopade 33:31–39
Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR (1999) Vertebral fractures and mortality in older women: a prospective study. Study of Osteoporotic Fractures Research Group. Arch Intern Med 159:1215–1220
Kang JD, An H, Boden S, Phillips F, Foley K, Abdu W (2003) Cement augmentation of osteoporotic compression fractures and intraoperative navigation: summary statement. Spine 28:S62–S63
Kasperk HC, Hillmeier J, Noldge G, Grafe IA, DaFonseca K, Raupp D (2005) Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective cohort study (Epub 2004). J Bone Mineral Res 20:604–612
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 11:13–15
Lane JM, Johnson CE, Khan SN, Girardi FP, Cammisa FP (2002) Minimally invasive options for the treatment of osteoporotic compression fractures. Orthop Clin North Am 33:431–438
Ledlie JT, Renfro M (2003) Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg 98:36–42
Levine SA, Perin LA, Hayes D (2000). An evidence based evaluation of percutaneous vertebroplasty. Manag Care 9:56–60
Lieberman IH, Dudeney S, Reinhardt M, Bell G (2001) Initial outcome and efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures. Spine 26:1631–1638
Lieberman I, Reinhardt MK (2003) Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop S176–S186
Lindsay R, Silverman SL, Cooper C (2001) Risk of new vertebral fracture in the year following a fracture. JAMA 285:320–323
MacLean CH, Morton SC, Ofman JJ, Roth EA, Shekelle PG (2003) How useful are unpublished data from the Food and Drug Administration in meta-analysis? J Clin Epidemiol 56:44–51
Masala S, Cesaroni A, Sergiacomi G, Fiori R, Massari F, Manenti G, Nardi P, Simonetti G (2004) Percutaneous kyphoplasty: new treatment for painful vertebral body fractures. In Vivo 18:149–153
Moore RA, Gavaghan D, Tremer MR, Collins Sl, McQuay HJ (1998) Size is everything-large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 78:209–216
National Institute for Clinical Excellence (2003) Interventional procedure overview of Balloon Kyphoplasty for vertebral compression fractures. http://www.nice.org.uk/IP179overview
National Institute for Clinical Excellence (2004) Guide to the methods of Technology Appraisal. pp 1–40. http://www.nice.org.uk
Old JL, Calvert M (2004) Vertebral compression fractures in the elderly. Am Fam Physician 69:111–116
Papaioannou A, Watts NB, Kendler DL, Yuen CK, Adachi JD, Ferko N (2002) Diagnosis and management of vertebral fractures in elderly adults. Am J Med 113:220–228
Phillips FM (2003) Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine 28:S45–S53
Phillips FM, Todd Wetzel F, Lieberman I, Campbell-Hupp M (2002) An in vivo comparison of the potential for extravertebral cement leak after vertebroplasty and kyphoplasty. Spine 27:2173–2178
Phillips FM, Ho E, Campbell-Hupp M, McNally T, Todd Wetzel F, Gupta P (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28:2260–2265
Rhyne A, Banit D, Laxer E, Odum S, Nussman D (2004) Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma 18:294–298
Riggs BL, Melton LJ (1995) The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone 17:S505–S511
Royle P, Waugh N (2003) Literature searching for clinical and cost-effectiveness studies used in health technology assessments reports carried out for the National Institute for Clinical Excellence appraisal system. Health Technol Assess 7(34):1–51
Schlaich C, Minne HW, Bruckner T (1998) Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int 8:261–267
Schwartz D (1981) Méthodes statistiques à l’usage des médecins et des biologistes. Flammarion Médecine-Science, Paris
Silverman SL (1992) The clinical consequences of vertebral compression fracture. Bone 13:S27–S31
Smith LA, Oldman AD, McQuay HJ, Moore RA (2000) Teasing apart quality and validity in systematic reviews: an example from acupuncture trials on chronic neck and back pain. Pain 86:119–132
Tamayo-Orozco J, Arzac-Palumbo P, Peon-Vidales H, Mota-Bolfeta R, Fuentes F (1997) Vertebral fractures associated with osteoporosis: patient management. Am J Med 103:S44–S50
Tang J, Liu JL (2000) Misleading funnel plot for detection of bias in meta-analysis. J Clin Epidemiol 53:477–484
The European Prospective Osteoporosis Study (EPOS) Group (2002) Incidence of vertebral fracture in Europe: Results from the European Prospective Osteoporosis Study (EPOS) J Bone Miner Res 17:716–724
Theodorou DJ, Theodorou SJ, Duncan TD, Garfin SR, Wong WH (2002) Percutaneous balloon kyphoplasty for the correction of spinal deformity in painful vertebral body compression fractures. Clin Imaging 26:1–5
Truumees E, Hilibrand A, Vaccaro AR (2004) Percutaneous vertebral augmentation. Spine J 4:218–229
Watts NB, Harris ST, Genant HK (2001) Treatment of painful osteoporotic vertebral fractures with percutaneous vertebroplasty or kyphoplasty. Osteoporos Int 12:429–437
Weisskopf M, Herlein S, Birnbaum K, Siebert C, Stanzel S, Wirtz DC (2003) Kyphoplastie - Ein neues minimalinvasives Verfahren zur Aufrichtung und Stabilisierung von Wirbelkorpern. [Kyphoplasty - a new minimally invasive treatment for repositioning and stabilising vertebral bodies]. Z Orthop Ihre Grenzgeb 141:406–411
Wilcox RK (2004) The biomechanics of Vertebroplasty: a review. Proc Inst Mech Eng [H ] 218:1–10
Wilhelm K, Stoffel M, Ringel F, Rao G, Rosseler L, Urbach H, Meyer B (2003) Ballon-Kyphoplastie zur Behandlung schmerzhafter osteoporotischer Wirbelkorperfrakturen - Technik und erste Ergebnisse. [Preliminary experience with balloon kyphoplasty for the treatment of painful osteoporotic compression fractures]. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 175:1690–1696
Wong W, Reiley MA, Garfin S (2000) Vertebroplasty/kyphoplasty. J Women’s Imaging 2:117–121
Yuan HA, Brown CW, Phillips FM (2004) Osteoporotic spinal deformity: a biomechanical rationale for the clinical consequences and treatment of vertebral body compression fractures. J Spinal Disord Tech 17:236–242
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Bouza, C., López, T., Magro, A. et al. Efficacy and safety of balloon kyphoplasty in the treatment of vertebral compression fractures: a systematic review. Eur Spine J 15, 1050–1067 (2006). https://doi.org/10.1007/s00586-005-0048-x
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DOI: https://doi.org/10.1007/s00586-005-0048-x