A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

Cristina Firanescu, Paul Nm Lohle, Jolanda de Vries, Caroline A Klazen, Job R Juttmann, William Clark, Willem Jan van Rooij, VERTOS IV study group, P N Lohle, W J van Rooij, J de Vries, J R Juttmann, M C Schoemaker, K Schoonenberg, C A Klazen, H Franken, F Jansen, A Tielbeek, M Blonk, M Vos, D R Halkema, F Meenhorst, O Elgersma, Cristina Firanescu, Paul Nm Lohle, Jolanda de Vries, Caroline A Klazen, Job R Juttmann, William Clark, Willem Jan van Rooij, VERTOS IV study group, P N Lohle, W J van Rooij, J de Vries, J R Juttmann, M C Schoemaker, K Schoonenberg, C A Klazen, H Franken, F Jansen, A Tielbeek, M Blonk, M Vos, D R Halkema, F Meenhorst, O Elgersma

Abstract

Background: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.

Methods: The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.

Discussion: The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.

Trial registration: This study is registered at ClinicalTrials.gov., NCT01200277.

References

    1. Incidence of vertebral fracture in Europe: results from the European Prospective Osteoporosis Study (EPOS) J Bone Miner Res. 2002;17:716–724. doi: 10.1359/jbmr.2002.17.4.716.
    1. Hasserius R, Karlsson MK, Jonsson B, Redlund-Johnell I, Johnell O. Long-term morbidity and mortality after a clinically diagnosed vertebral fracture in the elderly--a 12- and 22-year follow-up of 257 patients. Calcif Tissue Int. 2005;76:235–242. doi: 10.1007/s00223-004-2222-2.
    1. Galibert P, Deramond H, Rosat P, Le GD. [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty] Neurochirurgie. 1987;33:166–168.
    1. Zoarski GH, Snow P, Olan WJ, Stallmeyer MJ, Dick BW, Hebel JR, De DM. Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes. J Vasc Interv Radiol. 2002;13:139–148. doi: 10.1016/S1051-0443(07)61930-7.
    1. McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up. J Vasc Interv Radiol. 2002;13:883–886. doi: 10.1016/S1051-0443(07)61770-9.
    1. Legroux-Gerot I, Lormeau C, Boutry N, Cotten A, Duquesnoy B, Cortet B. Long-term follow-up of vertebral osteoporotic fractures treated by percutaneous vertebroplasty. Clin Rheumatol. 2004;23:310–317. doi: 10.1007/s10067-004-0914-7.
    1. Cortet B, Cotten A, Boutry N, Flipo RM, Duquesnoy B, Chastanet P, Delcambre B. Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: an open prospective study. J Rheumatol. 1999;26:2222–2228.
    1. McKiernan F, Faciszewski T, Jensen R. Quality of life following vertebroplasty. J Bone Joint Surg Am. 2004;86-A:2600–2606.
    1. Perez-Higueras A, Alvarez L, Rossi RE, Quinones D, Al-Assir I. Percutaneous vertebroplasty: long-term clinical and radiological outcome. Neuroradiology. 2002;44:950–954. doi: 10.1007/s00234-002-0856-1.
    1. Voormolen MH, Lohle PN, Lampmann LE, van den Wildenberg W, Juttmann JR, Diekerhof CH, de Waal MJ. Prospective clinical follow-up after percutaneous vertebroplasty in patients with painful osteoporotic vertebral compression fractures. J Vasc Interv Radiol. 2006;17:1313–1320. doi: 10.1097/01.RVI.0000231952.75209.4A.
    1. Anselmetti GC, Corrao G, Monica PD, Tartaglia V, Manca A, Eminefendic H, Russo F, Tosetti I, Regge D. Pain relief following percutaneous vertebroplasty: Results of a series of 283 consecutive patients treated in a single institution. Cardiovasc Intervent Radiol. 2007;30:441–7. doi: 10.1007/s00270-006-0146-0.
    1. Evans AJ, Jensen ME, Kip KE, DeNardo AJ, Lawler GJ, Negin GA, Remley KB, Boutin SM, Dunnagan SA. Vertebral compression fractures: pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty retrospective report of 245 cases. Radiology. 2003;226:366–372. doi: 10.1148/radiol.2262010906.
    1. Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine. 2006;3:1983–2001. doi: 10.1097/01.brs.0000229254.89952.6b.
    1. Diamond TH, Bryant C, Browne L, Clark WA. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust. 2006;184:113–117.
    1. Alvarez L, Alcaraz M, Perez-Higueras A, Granizo JJ, de M I, Rossi RE, Quinones D. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine (Phila Pa 1976) 2006;31:1113–8.
    1. Voormolen MH, Mali WP, Lohle PN, Fransen H, Lampmann LE, van der Graaf Y, Juttmann JR, Janssens X, Verhaar HJ. Percutaneous vertebroplasty compared with optimal pain medication treatment: Short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS Study. AJNR Am J Neuroradiol. 2007;28:555–560.
    1. Buchbinder R, Osborne RH, Ebeling PR. et al.A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361:557–568. doi: 10.1056/NEJMoa0900429.
    1. Kallmes DF, Comstock BA, Heagerty PJ. et al.A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361:569–579. doi: 10.1056/NEJMoa0900563.
    1. Klazen CA, Lohle PN, de Vries J. et al.Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376:1085–92. doi: 10.1016/S0140-6736(10)60954-3.
    1. Gangi A, Clark WA. Have recent vertebroplasty trials changed the indications for vertebroplasty? Cardiovasc Intervent Radiol. 2010;33:677–680. doi: 10.1007/s00270-010-9901-3.
    1. Baerlocher MO, Munk PL, Liu DM, Tomlinson G, Badii M, Kee ST, Loh CT, Hardy BW, Murphy KJ. Clinical utility of vertebroplasty: need for better evidence. Radiology. 2010;255:669–74. doi: 10.1148/radiol.10092107.
    1. Clark W, Goh AC. Vertebroplasty for acute osteoporotic spinal fractures-best evidence? J Vasc Interv Radiol. 2010;21:1330–3. doi: 10.1016/j.jvir.2010.06.008.
    1. Boszczyk B. Volume matters: a review of procedural details of two randomised controlled vertebroplasty trials of 2009. Eur Spine J. 2010. in press .
    1. Frankel B, Bloch DA. Sham or scam: a critical assessment of recent vertebroplasty trials. Neurosurgery. 2010;67:E521. doi: 10.1227/01.NEU.0000384041.72540.14.
    1. Genant HK, Wu CY, van KC, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993;8:1137–1148. doi: 10.1002/jbmr.5650080915.
    1. Huskisson EC. Measurement of pain. Lancet. 1974;2:1127–1131. doi: 10.1016/S0140-6736(74)90884-8.
    1. Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of Life in Patients with Vertebral Fractures: Validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Osteoporosis International. 1999;10:150–160. doi: 10.1007/s001980050210.
    1. Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8:141–144. doi: 10.1097/00007632-198303000-00004.
    1. Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine. 1983;8:145–150. doi: 10.1097/00007632-198303000-00005.

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