VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

Trials

Volumn 8, Issue , 2007, Pages

  Klazen, C A H ^a,b   Verhaar, H J J ^b   Lampmann, L E H ^a   Juttmann, J R ^a   Blonk, Marion C ^c   Jansen, Frits H ^c   Tielbeek, A V ^c   Schoemaker, M C ^a   Buskens, E ^b   van der Graaf, Y ^b   Janssens, Xavier ^d   Fransen, Hendrik ^d   van Everdingen, K J ^e   Muller, A F ^e   Mali, W P Th M ^b   Lohle, Paul N M ^a  

^a CPRLab   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c CATHARINA HOSPITAL   (Netherlands)

^d Algemeen Ziekenhuis Sint Lucas Gent   (Belgium)

^e DEPARTMENT OF SURGERY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; BONE CEMENT; CALCIUM; MORPHINE; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE DERIVATIVE; PARACETAMOL; TRAMADOL; VITAMIN D;

ADULT; ANALGESIA; ARTICLE; BACKACHE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONSERVATIVE TREATMENT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DRUG HYPERSENSITIVITY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FRAGILITY FRACTURE; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MINIMALLY INVASIVE SURGERY; MORTALITY; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OSTEOPOROSIS; PATIENT SAFETY; PERCUTANEOUS VERTEBROPLASTY; POSTOPERATIVE COMPLICATION; QUALITY OF LIFE; QUESTIONNAIRE; SYMPTOM; VERTEBRA FRACTURE; VISUAL ANALOG SCALE;

EID: 37749032620     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-8-33     Document Type: Article

References (27)

1. Incidence of vertebral fracture in europe: Results from the European Prospective Osteoporosis Study (EPOS) J Bone Miner Res 2002, 17:716-724 10.1359/jbmr.2002.17.4.716 11918229
2. 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 10.1007/s00223-004-2222-2 15812579
3. 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 3600949
4. 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 10.1016/S1051-0443(07)61930-7 11830619
5. 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 10.1016/S1051-0443(07)61770-9 12354821
6. 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 10.1007/ s10067-004-0914-7 15293091
7. 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 10529144
8. McKiernan F Faciszewski T Jensen R Quality of life following vertebroplasty J Bone Joint Surg Am 2004, 86-A:2600-2606 15590842
9. 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 10.1007/s00234-002-0856-1 12428134
10. Voormolen MH Lohle PN Lampmann LE van den WW 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 16923978
11. 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. 17200900
12. 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 10.1148/radiol.2262010906 12563127
13. Hulme PA Krebs J Ferguson SJ Berlemann U Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies Spine 2006, 31:1983-2001 10.1097/01.brs.0000229254.89952.6b 16924218
14. 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 16460295
15. 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 2006, 31:1113-1118 10.1097/ 01.brs.0000216487.97965.38 16648745
16. Voormolen MH Mali WP Lohle PN Fransen H Lampmann LE van der GY Juttmann JR Jansssens 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 17353335
17. Lee WS Sung KH Jeong HT Sung YS Hyun YI Choi JY Lee KS Ok CS Choi YW Risk factors of developing new symptomatic vertebral compression fractures after percutaneous vertebroplasty in osteoporotic patients Eur Spine J 2006, 15:1777-1783 10.1007/s00586-006-0151-7 16858596
18. Trout AT Kallmes DF Does vertebroplasty cause incident vertebral fractures? A review of available data AJNR Am J Neuroradiol 2006, 27:1397-1403 16908547
19. Trout AT Kallmes DF Kaufmann TJ New fractures after vertebroplasty: adjacent fractures occur significantly sooner AJNR Am J Neuroradiol 2006, 27:217-223 16418388
20. ClinicalTrials.gov 2005 http://www.clinicaltrials.gov
21. Genant HK Wu CY van KC Nevitt MC Vertebral fracture assessment using a semiquantitative technique J Bone Miner Res 1993, 8:1137-1148 8237484
22. Huskisson EC Measurement of pain Lancet 1974, 2:1127-1131 10.1016/ S0140-6736(74)90884-8 4139420
23. 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 10.1007/s001980050210 10501796
24. 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 10.1097/00007632-198303000-00004 6222486
25. 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 10.1097/00007632-198303000-00005 6222487
26. Lamers LM Stalmeier PF McDonnell J Krabbe PF van Busschbach JJ [Measuring the quality of life in economic evaluations: The Dutch EQ-5D tariff] Ned Tijdschr Geneeskd 2005, 149:1574-1578 16038162
27. Euroqol Group EQ-5D, an instrument to describe and value health. 2007 http://www.euroqol.org