Comparing Percutaneous Vertebroplasty and Conservative Therapy for Treating Osteoporotic Compression Fractures in the Thoracic and Lumbar Spine: A Systematic Review and Meta-Analysis.

BACKGROUND Vertebral compression fractures are a common complication of osteoporosis and are often treated by percutaneous vertebroplasty (PVP). The ability of this procedure to relieve pain better than conservative treatment is still debated. The purpose of this study was to compare the degree and duration of pain relief following PVP with that following conservative treatment for osteoporotic compression fractures by means of meta-analysis of randomized controlled trials. METHODS The CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Web of Science databases were queried for randomized controlled trials comparing PVP with conservative treatment or placebo/sham. The methodological quality was assessed according to the Cochrane Collaboration's domain-based evaluation framework. Random-effects meta-analysis of the raw mean difference between groups in change in pain level was performed, with sensitivity analyses and the Egger test for potential publication bias. RESULTS Of 209 records found, 11 were considered relevant, involving 1,048 participants. The risk of bias was considered low in 10 studies and high in 1. The 531 patients treated with PVP had a significantly lower pain level compared with the control group at 1 to 2 weeks, 2 to 3 months, and 12 months. The 95% CI (confidence interval) of the pooled effect size at every time interval included the score of 1.5, considered to be the minimal clinically important difference. The largest pooled effect size of -1.4 (95% CI, -2.3 to -0.5) was found during the first 1 to 2 weeks. The heterogeneity was high at all 3 time points (I(2), 71% to 96%). No significant publication bias was detected. CONCLUSIONS Up to 1 year postoperatively, the effect of PVP exceeded the effect of conservative therapy with respect to pain relief in patients with osteoporotic compression fractures. The effect size was significant and close to the minimal clinically important difference.

[1]  M. Saltychev,et al.  Medication of inclusion body myositis: a systematic review , 2016, Acta Neurologica Scandinavica.

[2]  Xinmin Feng,et al.  Comparing complications of vertebroplasty and kyphoplasty for treating osteoporotic vertebral compression fractures: a meta-analysis of the randomized and non-randomized controlled studies , 2015, European Journal of Orthopaedic Surgery & Traumatology.

[3]  Liangbi Xiang,et al.  The clinical efficacy of vertebroplasty on osteoporotic vertebral compression fracture: a meta-analysis. , 2014, International journal of surgery.

[4]  R. Buchbinder,et al.  Two‐Year Results of a Randomized Placebo‐Controlled Trial of Vertebroplasty for Acute Osteoporotic Vertebral Fractures , 2014, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[5]  Jianfei Tang,et al.  Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures , 2014, Journal of Clinical Neuroscience.

[6]  P. Heagerty,et al.  Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. , 2013, Radiology.

[7]  X. En,et al.  Percutaneous Kyphoplasty versus Conservative Treatment in Acute and Subacute Osteoporotic Vertebral Compression Fractures (OVCF): A Double-Blinded, Randomized Controlled Clinical Trial (RCT) in the Population of Western China , 2013 .

[8]  Xue-jun Cui,et al.  Comparing pain reduction following vertebroplasty and conservative treatment for osteoporotic vertebral compression fractures: a meta-analysis of randomized controlled trials. , 2013, Pain physician.

[9]  Jin Fan,et al.  Risk Factors for New Osteoporotic Vertebral Compression Fractures After Vertebroplasty: A Systematic Review and Meta-analysis , 2013, Journal of spinal disorders & techniques.

[10]  Huilin Yang,et al.  The long-term incidence of subsequent vertebral body fracture after vertebral augmentation therapy: a systemic review and meta-analysis. , 2012, Pain physician.

[11]  Wei Wang,et al.  Is There Really No Benefit of Vertebroplasty for Osteoporotic Vertebral Fractures? A Meta-analysis , 2012, Clinical orthopaedics and related research.

[12]  J. Macho,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 , 2012, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[13]  J. Hirsch,et al.  Percutaneous vertebroplasty in osteoporotic patients: an institutional experience of 1,634 patients with long-term follow-up. , 2011, Journal of vascular and interventional radiology : JVIR.

[14]  J. Blasco,et al.  Effect of vertebroplasty on the quality of life of patients with pain related to osteoporotic vertebral fractures , 2011 .

[15]  E. Alibai,et al.  Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. , 2011, Journal of neurosurgery. Spine.

[16]  J. de Vries,et al.  A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV) , 2011, Trials.

[17]  J. Vries,et al.  Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial , 2010, The Lancet.

[18]  J. Štulík,et al.  [Pulmonary polymethylmetacrylate embolism: a rare complication of percutaneous vertebroplasty]. , 2010, Acta chirurgiae orthopaedicae et traumatologiae Cechoslovaca.

[19]  L. Denaro,et al.  The effectiveness and safety of vertebroplasty for osteoporotic vertebral compression fractures. A double blind, prospective, randomized, controlled study. , 2010, Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases.

[20]  J. Lauritsen,et al.  Twelve-Months Follow-up in Forty-Nine Patients With Acute/Semiacute Osteoporotic Vertebral Fractures Treated Conservatively or With Percutaneous Vertebroplasty: A Clinical Randomized Study , 2010, Spine.

[21]  R. Buchbinder,et al.  A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. , 2009, The New England journal of medicine.

[22]  William Hollingworth,et al.  A randomized trial of vertebroplasty for osteoporotic spinal fractures. , 2009, The New England journal of medicine.

[23]  Joshua A Hirsch,et al.  Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Soci , 2009, Journal of vascular and interventional radiology : JVIR.

[24]  J. Hirsch,et al.  Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Soci , 2009, Journal of NeuroInterventional Surgery.

[25]  J. Lauritsen,et al.  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 , 2009, Spine.

[26]  J. Eisman,et al.  Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. , 2009, JAMA.

[27]  Peter Croft,et al.  Interpreting Change Scores for Pain and Functional Status in Low Back Pain: Towards International Consensus Regarding Minimal Important Change , 2008, Spine.

[28]  Y. van der Graaf,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. , 2007, AJNR. American journal of neuroradiology.

[29]  O. Johnell,et al.  An estimate of the worldwide prevalence and disability associated with osteoporotic fractures , 2006, Osteoporosis International.

[30]  A. Vaccaro,et al.  Osteoporotic compression fractures of the spine; current options and considerations for treatment. , 2006, The spine journal : official journal of the North American Spine Society.

[31]  D. Kallmes,et al.  Does vertebroplasty cause incident vertebral fractures? A review of available data. , 2006, AJNR. American journal of neuroradiology.

[32]  J. Eisman,et al.  Prevalent vertebral deformities: Relationship to bone mineral density and spinal osteophytosis in elderly men and women , 2005, Osteoporosis International.

[33]  L. Bastian,et al.  Does this woman have osteoporosis? , 2004, JAMA.

[34]  J. Cardella,et al.  Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. , 2003, Journal of vascular and interventional radiology : JVIR.

[35]  J. Mathis,et al.  Vertebroplasty in Osteoporosis , 2002, Seminars in musculoskeletal radiology.

[36]  Theo Stijnen,et al.  Advanced methods in meta‐analysis: multivariate approach and meta‐regression , 2002, Statistics in medicine.

[37]  A. Rapado.  General management of vertebral fractures. , 1996, Bone.

[38]  L. Melton,et al.  The worldwide problem of osteoporosis: insights afforded by epidemiology. , 1995, Bone.

[39]  F. Christopher.  Compression fractures of the spine , 1930 .