Abstract

BACKGROUND CONTEXT Previously, a randomized controlled trial (RCT) in the New England Journal of Medicine concluded that vertebroplasty for osteoporotic vertebral compression fractures (VCFs) provided no clinical benefit over sham surgery. However, the VCFs examined had no clinical correlation with symptoms, physical exam, or imaging (MRI/bone scan) findings. Nonetheless, the RCT resulted in a reduction in vertebral augmentation (VA) performed in the United States. Currently, no consensus exists on VA versus nonoperative care for symptomatic VCFs. PURPOSE This study's goal was to (i) assess the clinical outcomes with and without VA for osteoporotic VCFs with versus without correlating signs and symptoms; and (ii) acute (symptoms less than 3 months duration) and sub-acute VCFs (3-6 months duration) versus chronic VCFs (greater than 6 months). STUDY DESIGN/SETTING This study is a meta-analysis. PATIENT SAMPLE A total of 1,467 patients from 13 studies were included in this meta-analysis. Weighted mean patient age is 74 years and range from 64 to 80 years. The reported sex of the patient population is 16% male. OUTCOME MEASURES The following data was extracted from the 13 studies that fulfilled inclusion criteria: year of study, level of evidence, type of surgery, number of cases, the proportion of male patients, patients’ age, and duration of symptoms. The primary outcome of interest was VAS back pain. METHODS A literature search was conducted for studies on VA and conservative management for VCFs. Meta-analysis was performed using the random-effects model. The primary outcome was improvement in lower back pain visual analog score. Symptomatic VCFs (SVFs) was defined as radiographic VCF with clinical correlation. Radiographic-alone VCFs (RVFs) was defined as radiographic VCF without clinical correlation. RESULTS Thirteen studies totaling 1,467 patients with minimum 6 months follow-up were found. Pain reduction was greater with VA over conservative management for SVFs (p CONCLUSIONS VA is superior to nonoperative care in reducing lower back pain for osteoporotic VCFs with correlating signs and symptoms. VA had no benefit over nonoperative care for chronic VCFs that lacked clinical correlation. Lower back pain has many etiologies and patients should be clinically assessed prior to recommending VA. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

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