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Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis

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Abstract

This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.

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Correspondence to Rod S. Taylor.

Additional information

This report has been undertaken through unrestricted funding by Kyphon Inc. The planning, conduct and conclusions of this report are made independently from the company.

Appendix

Appendix

1. Included studies

Comparative

i. 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) 98:21–30E2

ii. Grohs JG, Matzner M, Trieb K, Krepler P (2005) Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomised comparison of vertebroplasty and balloon kyphoplasty. J Spinal Disord Tech 18:238–242

iii. (i) Kasperk C, Hillmeier J, Noldge G, Grafe IA, Dafonseca K, Raupp D, Bardenheuer H, Libicher M, Liegibel UM, Sommer U, Hilscher U, Pyerin W, Vetter M, Meinzer HP, Meeder PJ, Nawroth P, Taylor RS (2005) Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomised controlled study. J Bone Miner Res 20:604–612

(ii) Grafe IA, Da Fonseca K, Hillmeier J, Meeder PJ, Libicher M, Noldge G, Bardenheuer H, Pyerin W, Basler L, Weiss C, Taylor RS, Nawroth P, Kasperk C (2005) Reduction of pain and fracture incidence after kyphoplasty: 1-year outcomes of a prospective controlled trial of patients with primary osteoporosis. Osteoporos Int 16:2005–2012

(iii) Grafe I, DeFonseca K, Hillmeier J, Meeder P-J, Libicher M, Nodge G, ommer M, Hilscher U, Naworth P, Kasperk C. Kyphoplasty persistently reduces pain in patients with osteoporotic vertebral compression fractures—3 year outcome of a prospectively controlled cohort study. IOF World Congress of Osteoporosis. 2nd June 2006, Toronto, Canada

iv. 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

v. Masala S et al (2004) Vertebroplasty and kyphoplasty in treatment of malignant vertebral fractures. J Chemotherapy 16(Suppl 5):30–33

vi. Nussbaum DA, Gailloud P, Murphy K (2004) A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. J Vas Interven Radiol 15:1185–1192

vii. Pflugmacher R, Kandziora K, Schröder R, Schleicher P, Scholz M, Schnake Haas K, Khodadadyan-Klostermann C (2005) Vertebroplasty and kyphoplasty in osteoporotic fractures of vertebral bodies—a prospective 1-year follow-up analysis. Fortschr Röntgenstr 177:1670–1676

viii. Weisskopf M, Herlein S, Birnbaum K et al (2003) Kyphoplasty—a new minimal invasive treatment for repositioning and stabilising vertebral bodies. Zeit fur Orthop und Inre Grenz 141:406–411

Case series

ix. Atalay B, Caner H, Gokce C, Altinors N (2005) Kyphoplasty: 2 years of experience in a neurosurgery department. Surg Neurol 64(Suppl 2):S72–S76

x. Buisson T, Beaudic Y, Godard J, Czorny A, Grumblat A (2005) Fractures du rachis traitees par cyphoplastie avec ballonets. Etude preliminary sur 6 cas. La Revue de l’ADPHSO 30:79–83

xi. Coumans JV, Reinhardt M-K, Lieberman IH (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg 99(Suppl 1): 44–50

xii. 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

xiii. Darius T, Vanderschot P, Broos P (2003) Balloon kyphoplasty: a new treatment option for painful osteoporotic vertebral body compression fractures. Tijdschrift voor Geneekuunde 59:1141–1152

xiv. 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

xv. Feltes C, Fountas KN, Machinis T, Nikolakakos LG, Dimopoulos V, Davydov R, Kassam M, Johnston KW, Robinson JS (2005) Immediate and early postoperative pain relief after kyphoplasty without significant restoration of vertebral body height in acute osteoporotic vertebral fractures. Neurosurg Focus 18:e5

xvi. Fribourg D, Tang C, Sra P, Delamarter R, Bae H (2004) Incidence of subsequent vertebral fracture after kyphoplasty. Spine 29:2270–2276

xvii. Gaitanis IN, Hadjipavlou AG, Katonis PG, Tzermiadianos MN, Pasku DS, Patwardhan AG (2005) Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures. Eur Spine J 14:250–256

xviii. (i) Garfin SR. A multi-center postmarketing registry to assess outcomes of treatment of vertebral body compression fractures with an inflatable bone tamp. Final report 2003 (Kyphon registry report—unpublished)

(ii) Garfin SR, Buckley RA, Ledlie J (2006) Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine (in press)

xix. Grohs JG, Krepler P (2004) Minimal-invasive stabilisierung osteoporotischer wirbelkorpereinbruche. Radiologe 44:254–259

xx. 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

xxi. Hillmeier J, Meeder PJ, Noldge G et al (2003) Minimal invasive reduction and internal stabilisation of osteoporotic vertebral body fracture. Oper Orthop Traumatol 4:343–362

xxii. Hillmeier J, Grafe I, Da Fonseca K, Meeder PJ, Noldge G, Libicher M, Kock HJ, Haag M, Kasperk C (2004) The evaluation of balloon kyphoplasty for osteoporotic vertebral fractures. An interdisciplinary concept. Orthopade 33:893–904

xxiii. Khanna AJ, Reinhardt MK, Togawa D, Lieberman IH (2006) Functional outcomes of kyphoplasty for the treatment of osteoporotic and osteolytic vertebral compression fractures. Osteoporos Int 17:817–826

xxiv. Kasperk C et al (2003) Kyphoplastie—Konzept zur behandlung schmerzhafter wirbelkorperbruch. Deutsches Afzteblatt 100:1748–1753

xxv. Lane JM, Hong R, Koob J, Kiechle T, Niesvizky R, Pearse R, Siegel D, Poynton AR (2004) Kyphoplasty enhances function and structural alignment in multiple myeloma. Clin Orthop Relat Res 426:49–53

xxvi. (i) Ledlie JT, Renfro MB (2005) Decreases in the number and severity of morphometrically defined vertebral deformities after kyphoplasty. Neurosurg Focus 18:e4

(ii) Ledlie JT, Renfro M (2003) Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain and activity levels. J Neurosurg (Spine 1) 98(Suppl 1):36–42

(iii) Ledlie JT, Refro MB (2006) Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefit. Spine 31:57–64

xxvii. Lieberman IH, Dudeney S, Reinhardt M-K et al (2001) Initial outcome and efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures. Spine 26:1631–1638

xxviii. Lieberman I, Reinhardt MK (2003) Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop Relat Res 415S:S176–S186

xxix. Libicher M, Vetter M, Wolf I, Noeldge G, Kasperk C, Grafe I, Da Fonseca K, Hillmeier J, Meeder PJ, Meinzer HP, Kauffmann GW (2005) CT volumetry of intravertebral cement after kyphoplasty. Comparison of polymethylmethacrylate and calcium phosphate in a 12-month follow-up. Eur Radiol 13:1544–1549

xxx. Majd ME, Farley S, Holt R (2005) Preliminary outcomes and efficacy of the first 360 consecutive kyphoplasties for the treatment of painful osteoporotic vertebral compression fractures. Spine J 5:244–255

xxxi. Masala S, Cesaroni A, Sergiaconi G, Fiori R et al (2004) Percutaneous kyphoplasty: new treatment for painful vertebral body fractures. In Vivo 18:149–154

xxxii. Masala S, Fiori R, Massari F, Simonetti G (2005) Kyphoplasty: indications, contraindications and technique. La Radiologia Medica 110:97–105

xxxiii. Phillips FM, Wetzel FT, Lieberman I et al (2002) An in vivo comparison of the potential for extravertebral cement leak after vertebroplasty and kyphoplasty. Spine 27:2173–2178

xxxiv. Phillips FM, Ho E, Campbell-Hupp M et al (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28

xxxv. Pradhan BB, Bae HW, Kropf MA, Patel VV, Delamarter RB (2006) Kyphoplasty reduction of osteoporotic vertebral compression fractures: correction of local kyphosis versus overall sagittal alignment. Spine 31:435–441

xxxvi. Rhyne A, Banit D, Laxer E, Odum S, Nussman D (2004) Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma 18:294–299

xxxvii. Tang H, Lu Y, Wang BQ, Chen H (2005) The study of treatment of osteoporotic thoracolumbar multi-vertebral compressive fractures by kyphoplasty with one balloon. Zhonghua Wai Ke Za Zhi 43:1568–7151

xxxviii. Theodorou DJ, Theodorou SJ, Duncan TD et al (2002) Percutaneous balloon kyphoplasty for the correction of spinal deformity in painful vertebral compression fractures. J Clin Imaging 26:1–5

xxxix. Villavicencio AT, Burneikiene S, Bulsara K, Thramann JT (2005) Intraoperative three-dimensional fluoroscopy-based computerized tomography guidance for percutaneous kyphoplasty. Neurosurg Focus 18:E3

xl. Voggenreiter G, Brocker K, Düber C, Obertacke U, Röhrl B, Sadik M (2004) Behandlungsergebnisse der Ballonkyphoplastik bei osteoporotischen Wirbelkörperfrakturen im höheren Lebensalter. J für Mineralstoffwechsel 11:12–14

xli. Voggenreiter G (2005) Balloon kyphoplasty is effective in deformity correction of osteoporotic vertebral compression fractures. Spine 30:2806–2812

xlii. Wilhelm K, Stoffel M, Ringel F et al (2003) Preliminary experience with balloon kyphoplasty for the treatment of painful osteoporotic fractures. Rofo Fortschritte auf dem Gebeite der Rontgenstrahlen und der Neuen Bildgebenden Verfahren 175:1690–1696

xliii. Yang HL, Niu GQ, Liang DC, Wang GL, Meng B, Chen L, Lu J, Zhou Y, Mao HQ, Zhao LJ, Liu XY, Gu XH, Ni CF, Tang TS (2004) The contrast study between single and double balloon bilateral dilatation of kyphoplasty Chin J Surg 42:1299–1302

2. Studies excluded on the basis of full paper

Acosta FL Jr. Aryan HE. Taylor WR. Ames CP (2005) Kyphoplasty-augmented short-segment pedicle screw fixation of traumatic lumbar burst fractures: initial clinical experience and literature review. Neurosurg Focus 18:e9. (burst fractures and combined treatment)

Berlemann U, Franz T, Orler R, Heini PF (2004) Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective non-randomised study. Eur Spine J 13:496–501 (open procedure and traumatic fractures)

Heini PF, Orler R (2004) Kyphoplasty for treatment of osteoporotic fractures. Eur Spine J 13:184–192 (duplicate publication)

Boszczyk BM, Bierschneider M, Hauck S, Vastmans J, Potulski M, Beisse R, Robert B, Jaksche H (2004) Conventional and semi-open kyphoplasty. Orthopede 33:13–21 (review and open procedure)

Boszczyk BM et al (2004) Microsurgical interlaminary vertebro- and kyphoplasty for severe osteoporotic fractures. J Neurosurg (Spine 1) 100:32–37 (open procedure)

de Falco R, Scarano E, Di Celmo D, Grasso U, Guarnieri L (2005) Balloon kyphoplasty in traumatic fractures of the thoracolumbar junction. Preliminary experience in 12 cases. J Neurosurg Sci 49:147–153 (traumatic fractures)

Deen HG, Nottmeier EW (2005) Balloon kyphoplasty for treatment of sacral insufficiency fractures. Report of three cases. Neurosurg Focus 18(3):e7 (type of fracture)

Deen HG, Aranda-Michel J, Reimer R, Putzke JD (2005) Preliminary results of balloon kyphoplasty for vertebral compression fractures in organ transplant recipients. Neurosurg Focus 18(3):e6 (patient population)

Gerszten PC, Germanwala A, Burton SA, Welch WC, Ozhasoglu C, Vogel WJ (2005) Combination kyphoplasty and spinal radiosurgery: a new treatment paradigm for pathological fractures. Neurosurg Focus 18(3):e8 (combination treatment)

Hentschel SJ, Burton AW, Fourney DR, Rhines LD, Mendel E (2005) Percutaneous vertebroplasty and kyphoplasty performed at a cancer center: refuting proposed contraindications. J Neurosurg Spine 2:436–440 (balloon kyphoplasty and vertebroplasty outcomes reported combined)

Ronge R (2005) Complications after vertebroplasty and kyphoplasty–cement emboli recognized on typical radiographic images. Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin 17:934. (no data reported)

Tomita S, Kin A, Yazu M, Abe M (2003) Biomechanical evaluation of kyphoplasty and vertebroplasty with calcium phosphate cement in a simulated osteoporotic compression fracture. J Orthop Sci 8:192–197 (cadaver)

Palussière J, Berge J, Gangi A, Cotton A, Pasco1 A, Bertagnoli R, Jaksche1 H, Carpeggiani P, Deramond H (2005) Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation. Eur Spine J 14:982–991 (inappropriate intervention)

Schulte BU, Brucher D, Trompeter M, Remy C, Reimer P (2006) Balloon-assisted percutaneous vertebroplasty in patients with osteoporotic vertebral body compression fractures–first results Rofo 178:207–213. (inappropriate intervention)

Verlaan J-J, Dhert WJA, Verbout AJ Oner FCS ((2005) Balloon vertebroplasty in combination with pedicle screw instrumentation: a novel technique to treat thoracic and lumbar burst fractures. Spine 30:e73–e79 (burst factures)

Wong W, Mathis JM (2005) Vertebroplasty and kyphoplasty: techniques for avoiding complications and pitfalls Neurosurg Focus 18:E2 (hypothetical cases)

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Taylor, R.S., Fritzell, P. & Taylor, R.J. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis . Eur Spine J 16, 1085–1100 (2007). https://doi.org/10.1007/s00586-007-0308-z

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