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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>This study is registered at ClinicalTrials.gov., <a href="http://www.clinicaltrials.gov/ct2/show/NCT01200277">NCT01200277</a>.</p

The contribution of RCTs to quality management and their feasibility in practice

The randomized controlled trial (RCT) is generally accepted as the most reliable method of conducting clinical research. To obtain an unbiased evaluation of the effectiveness of spine surgery, patients should be randomly assigned to either new or standard treatment. The aim of the present article is to provide a short overview of the advantages and challenges of RCTs and to present a summary of the conclusions of the Cochrane Reviews in spine surgery and later published trials in order to evaluate their contribution to quality management and feasibility in practice. From the searches, 130 RCTs were included, 95 from Cochrane Reviews and systematic reviews, and 35 from additional search. No study comparing surgery with sham surgery was identified. The first RCT in spine surgery was published in 1974 and compared debridement and ambulatory treatment in tuberculosis of the spine. The contribution of RCTs in spinal surgery has markedly increased over the last 10 years, which indicates that RCTs are feasible in this field. The results demonstrate missing quality specifications. Despite the number of published trials there is conflicting or limited evidence to support various techniques of instrumentation. The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica. For future trials, authors, referees, and editors are recommended to follow the CONSORT statement. RCTs provide evidence to support clinical opinions before implementation of new techniques, but the individual clinical experience is still important for the doctor who has to face the patient

Non-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club

This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip protectors. Vertebroplasty is also briefly reviewed. Non-pharmacological management of osteoporosis is a broad concept. It must be viewed as an essential part of the prevention of fractures from childhood through adulthood and the old age. The topic also includes surgical procedures for the treatment of peripheral and vertebral fractures and the post-fracture rehabilitation. The present document is the result of a consensus, based on a systematic review and a critical appraisal of the literature. Diets deficient in calcium, proteins or vitamin D impair skeletal integrity. The effect of other nutriments is less clear, although an excessive consumption of sodium, caffeine, or fibres exerts negative effects on calcium balance. The deleterious effects of tobacco, excessive alcohol consumption and a low BMI are well accepted. Physical activity is of primary importance to reach optimal peak bone mass but, if numerous studies have shown the beneficial effects of various types of exercise on bone mass, fracture data as an endpoint are scanty. Fall prevention strategies are especially efficient in the community setting, but less evidence is available about their effectiveness in preventing fall-related injuries and fractures. The efficacy of hip protectors remains controversial. This is also true for vertebroplasty and kyphoplasty. Several randomized controlled studies had reported a short-term advantage of vertebroplasty over medical treatment for pain relief, but these findings have been questioned by recent sham-controlled randomized clinical studies

Percutaneous vertebroplasty for subacute and chronic painful osteoporotic vertebral compression fractures can safely be undertaken in the first year after the onset of symptoms

Imaging- and therapeutic targets in neoplastic and musculoskeletal inflammatory diseas