Systematic Review and Meta-Analysis of 3 Treatment Arms for Vertebral Compression Fractures

Abstract

Background: Osteoporotic vertebral fractures (OVFs) have become increasingly common, and previous nonrandomized and randomized controlled trials (RCTs) have compared the effects of cement augmentation versus nonoperative management on the clinical outcome. This meta-analysis focuses on RCTs and the calculated differences between cement augmentation techniques and nonsurgical management in outcome (e.g., pain reduction, adjacent-level fractures, and quality of life [QOL]). Methods: A systematic review was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, and the following scientific search engines were used: MEDLINE, Embase, Cochrane, Web of Science, and Scopus. The inclusion criteria included RCTs that addressed different treatment strategies for OVF. The primary outcome was pain, which was determined by a visual analog scale (VAS) score; the secondary outcomes were the risk of adjacent-level fractures and QOL (as determined by the EuroQol-5 Dimension [EQ-5D] questionnaire, the Oswestry Disability Index [ODI], the Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO], and the Roland-Morris Disability Questionnaire [RDQ]). Patients were assigned to 3 groups according to their treatment: vertebroplasty (VP), kyphoplasty (KP), and nonoperative management (NOM). The short-term (weeks), midterm (months), and long-term (>1 year) effects were compared. A random effects model was used to summarize the treatment effect, including I 2 for assessing heterogeneity and the revised Cochrane risk-of-bias 2 (RoB 2) tool for assessment of ROB. Funnel plots were used to assess risk of publication bias. The log of the odds ratio (OR) between treatments is reported. Results: After screening of 1,861 references, 53 underwent full-text analysis and 16 trials (30.2%) were included. Eleven trials (68.8%) compared VP and NOM, 1 (6.3%) compared KP and NOM, and 4 (25.0%) compared KP and VP. Improvement of pain was better by 1.31 points (95% confidence interval [CI], 0.41 to 2.21; p < 0.001) after VP when compared with NOM in short-term follow-up. Pain effects were similar after VP and KP (midterm difference of 0.0 points; 95% CI, −0.25 to 0.25). The risk of adjacent-level fractures was not increased after any treatment (log OR, −0.16; 95% CI, −0.83 to 0.5; NOM vs. VP or KP). QOL did not differ significantly between the VP or KP and NOM groups except in the short term when measured by the RDQ. Conclusions: This meta-analysis provides evidence in favor of the surgical treatment of OVFs. Surgery was associated with greater improvement of pain and was unrelated to the development of adjacent-level fractures or QOL. Although improvements in sagittal balance after surgery were poorly documented, surgical treatment may be warranted if pain is a relevant problem. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Vertebral Augmentation in Spine Surgery

“…8 These findings have subsequently been supported by several other studies and meta-analyses that show superior improvement in pain scores in patients treated with percutaneous cement augmentation versus conservative management, specifically in patients who have acute fractures with persistent and severe pain. 9-11 These studies have also shown similar outcomes in pain reduction when comparing PVP and PKP.…”

“…8 These findings have subsequently been supported by several other studies and meta-analyses that show superior improvement in pain scores in patients treated with percutaneous cement augmentation versus conservative management, specifically in patients who have acute fractures with persistent and severe pain. [9][10][11] These studies have also shown similar outcomes in pain reduction when comparing PVP and PKP. More recent studies looking at TIVAD have shown promising results compared with PKP, although there are currently limited data for the TIVAD procedure compared with classic cement augmentation procedures.…”

Management of Chronic Low Back Pain

“…Most physicians and guidelines recommend a trial of conservative management with nonopioid analgesics and rehabilitative treatment before proceeding to invasive treatments. In fact, many interventional studies require that patients fail to achieve adequate pain relief and/or functional improvement from rehabilitative treatment prior to enrollment …”

“…Although the present review asserts a lack of evidence to support interventional treatments, it does not account for the effectiveness of various treatments based on specific diagnoses. There are numerous high-quality studies that have demonstrated excellent clinical outcomes and cost-effectiveness when patients are properly diagnosed and treated accordingly …”

Management of Chronic Low Back Pain—Reply

“…In contrast, a systematic review and meta-analysis of 8 placebo- or sham-controlled RCTs of spinal cord stimulation compared with conventional therapy failed to show any clinically meaningful difference in a 10-point visual analog scale (VAS difference, 1.15; minimally important difference [MID], 1.4) . The second review compared vertebroplasty and kyphoplasty with nonoperative management in 12 trials, of which 4 were sham procedure controlled . These studies again failed to meet the MID of 1.4 on the 10-point VAS pain scale, in both the short term (VAS difference, 1.31) and long term (VAS difference, 0.9).…”