Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures

Journal of Bone and Mineral Research

Volumn 29, Issue 6, 2014, Pages 1346-1355

  Kroon, Féline ^a,b   Staples, Margaret ^a,c   Ebeling, Peter R ^d   Wark, John D ^d   Osborne, Richard H ^e   Mitchell, Peter J ^d   Wriedt, Chris H R ^f   Buchbinder, Rachelle ^a,c  

^a CABRINI INSTITUTE   (Australia)

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c MONASH UNIVERSITY   (Australia)

^d UNIVERSITY OF MELBOURNE   (Australia)

^e DEAKIN UNIVERSITY   (Australia)

^f I Med Network Ltd   (Australia)

Author keywords

CLINICAL TRIALS; INJURY FRACTURE HEALING; OSTEOPOROSIS; THERAPEUTICS

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; BONE CEMENT; PLACEBO;

AGED; ARTICLE; CEMENT LEAKAGE; CONTROLLED STUDY; DISEASE DURATION; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; FRAGILITY FRACTURE; GENDER; HUMAN; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PERCUTANEOUS VERTEBROPLASTY; PHYSICAL DISABILITY; QUALITY OF LIFE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REST; SHAM PROCEDURE; SPINE FRACTURE; COMPLICATION; DISABILITY; OSTEOPOROTIC FRACTURES; PAIN, POSTOPERATIVE; QUESTIONNAIRE; SPINAL FRACTURES; TREATMENT OUTCOME;

AGED; DISABILITY EVALUATION; FEMALE; HUMANS; MALE; OSTEOPOROTIC FRACTURES; PAIN, POSTOPERATIVE; PLACEBOS; QUESTIONNAIRES; SPINAL FRACTURES; TREATMENT OUTCOME; VERTEBROPLASTY;

EID: 84901255326     PISSN: 08840431     EISSN: 15234681     Source Type: Journal    
DOI: 10.1002/jbmr.2157     Document Type: Article

References (43)

1. Voormolen M, Mali W, Lohle P, et al. 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: 555-60.
2. Rousing R, Andersen M, Jespersen S, Thomsen K, Lauritsen J., Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine. 2009; 34: 1349-54.
3. Buchbinder R, Osborne R, Ebeling P, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361: 557-68.
4. Kallmes D, Comstock B, Heagerty P, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009; 361: 569-79.
5. Klazen C, Lohle P, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25; 376 (9746): 1085-92.
6. Farrokhi MR, Alibai E, Maghami Z., Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011; 14: 561-9.
7. Blasco J, Martinez-Ferrer A, Macho J, et al. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012; 27: 1159-66.
8. Staples M, Kallmes D, Comstock B, et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ. 2011; 342: d3952.
9. Buchbinder R, Osborne R, Ebeling P, et al. Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised controlled trial. BMC Musculoskel. 2008; 9: 156.
10. Genant HK, Wu CY, van Kuijk C, Nevitt MC., Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993; 8: 1137-48.
11. Grotle M, Brox JI, Vøllestad NK., Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine. 2004; 29: E492-501.
12. Huskisson E., Measurement of pain. J Rheumatol. 1982; 9: 768-9.
13. Trout AT, Kallmes DF, Gray LA, et al. Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire. AJNR Am J Neuroradiol. 2005; 26: 2652-7.
14. Lips P, Cooper C, Agnusdei D, et al. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteopor Int. 1999; 10: 150-60.
15. Hawthorne G, Osborne R., Population norms and meaningful differences for the Assessment of Quality of Life (AQoL) measure. Aust N Z J Public Health. 2005; 29: 136-42.
16. Walters S, Brazier J., Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005; 14: 1523-32.
17. Podsiadlo D, Richardson S., The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991; 39: 142-8.
18. McNutt L, Wu C, Xue X, Hafner J., Estimating the relative risk in cohort studies and clinical trials of common outcomes. Am J Epidemiol. 2003; 157: 940-3.
19. James D, Bloch D, Lee K, Kraemer H, Fuller R., An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation: a VA cooperative study. Stat Med. 1996; 15: 1421-34.
20. Álvarez L, Alcarez M, Pérez-Higueras A, et al. Percutaneous vertebroplasty: functional improvement in patients with osteoporotic compression fractures. Spine. 2006; 31: 1113-8.
21. Diamond TH, Champion B, Clark WA., Management of acute osteoporotic vertebral fractures: a nonrandomized trial comparing percutaneous vertebroplasty with conservative therapy. Am J Med. 2003; 114: 257-65.
22. Psaty B, Prentice R., Minimizing bias in randomized trials. JAMA. 2010; 304: 793-4.
23. Wood L, Egger M, Gluud L, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008; 36: 601-5.
24. Moerman DE, Jonas WB., Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. 2002; 136: 471-6.
25. Baerlocher M, Munk P, Liu D, et al. Clinical utility of vertebroplasty: need for better evidence. Radiology. 2010; 255: 669-74.
26. Baerlocher M, Munk P, Liu D., Trials of vertebroplasty for vertebral fractures. N Engl J Med. 2009; 361: 2098.
27. Bono C, Heggeness M, Mick C, Resnick D, Watters W., Newly released vertebroplasty RCTs: a tale of two trials. Spine J. 2010; 10: 238-2340.
28. Clark W, Lyon S, Burnes J., Trials of vertebroplasty for vertebral fractures. N Engl J Med. 2009; 361: 2097-8.
29. Clark W, Diamond T, McNeil H, Gonski P, Schlaphoff G, Rouse J., Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty. Med J Aust. 2010; 192: 334-7.
30. Gangi A, Clark W., Have recent vertebroplasty trials changed the indications for vertebroplasty ? Cardiovasc Intervent Radiol. 2010; 33: 677-80.
31. Carragee E., The vertebroplasty affair: the mysterious case of the disappearing effect size. Spine J. 2010; 10: 191-2.
32. Buchbinder R, Kallmes D., Vertebroplasty: when randomized placebo-controlled trial results clash with common belief. Spine J. 2010; 10: 241-3.
33. Buchbinder R, Osborne R, Kallmes D., Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty. Med J Aust. 2010; 192: 338-41.
34. Buchbinder R, Osborne R, Staples M, Response to Letters to the Editor [in reference to the following article: Buchbinder et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361: 557-68. DOI: 10.1056/NEJMoa0900429]. New Engl J Med. 2009; 361: 2099. Available from: http://www.nejm.org/doi/full/10.1056/NEJMoa0900429#t=letters.
35. Kallmes D, Buchbinder R, Jarvik J, Heagerty P, Turner J, Osborne R., Response to "Randomized Vertebroplasty Trials: Bad News or Sham News? ". AJNR Am J Neuroradiol. 2009; 30: 1809-10.
36. Kallmes D, Jarvik J, Osborne R, et al. Clinical utility of vertebroplasty: elevating the evidence. Radiology. 2010; 255: 675-80.
37. Kallmes D, Buchbinder R, Miller F., Viewpoint: Randomised controlled trials using invasive control interventions should be included in Cochrane Reviews. Cochrane Database Syst Rev. 2011; 8: ED000030.
38. Miller F, Kallmes D, Buchbinder R., Vertebroplasty and the placebo response. Radiology. 2011 Jun; 259 (3): 621-5.
39. Wardlaw D, Cummings S, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009; 373: 1016-24.
40. Kaufmann TJ, Trout AT, Kallmes DF., The effects of cement volume on clinical outcomes of percutaneous vertebroplasty. AJNR Am J Neuroradiol. 2006; 27: 1933-7.
41. Al-Ali F, Barrow T, Luke K., Vertebroplasty: what is important and what is not. AJNR Am J Neuroradiol. 2009; 30: 1835-9.
42. Klazen C, Venmans A, de Vries J, et al. Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2010; 31: 1447-50.
43. McCullough B, Comstock B, Deyo R, Kreuter W, Jarvik J., Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013; 173: 1514-21.