The effectiveness of balloon kyphoplasty compared to conservative treatment for osteoporotic vertebral compression fractures: A systematic review and meta-analysis

Sebastian Encalada , Christine Hunt , Belinda Duszynski , Vafi Salmasi , Paul Scholten , Zirong Zhao , George Rappard , William Evan Rivers , To-Nhu Vu , Steven Lobel , Adrian Popescu , Larry J. Prokop , D. Scott Kreiner
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Abstract

Background

Osteoporotic vertebral compression fractures (OVCFs) are a common and often debilitating condition that significantly impacts quality of life and healthcare costs. While conservative treatment is often pursued initially after fracture, some patients experience severe pain refractory to conservative treatment. In these cases, minimally invasive vertebral augmentation procedures like balloon kyphoplasty (BKP) offer an alternative, but the benefits of BKP compared to conservative treatment remain unclear.

Objectives

To evaluate the effectiveness of BKP versus conservative treatment for pain, quality of life, and function in patients with painful OVCFs.

Primary outcome

Pain improvement up to 12 months after BKP.

Secondary outcomes

Functional improvement, adverse events, and vertebral body height restoration.

Methods

This analysis included randomized controlled trials and prospective comparative studies in which at least 100 participants reported pain outcomes following BKP for OVCFs. The risk of bias was assessed using standard tools, and the certainty of the evidence was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach.

Results

BKP demonstrated superior pain reduction versus conservative treatment at 1 month (mean difference (MD): 2.32 [-3.65;-0.99], P < 0.001), 3 months (MD: 1.19 [-2.14; −0.24], P = 0.014), 6 months (MD: 1.34 [-2.65; −0.04], P = 0.044), and 12 months (MD: 1.11 [-1.96;-0.26], P = 0.029), with the largest effect observed at 1 month. Disability improvements were significant at 1 month (standardized mean difference (SMD): 1.08 [-1.67; −0.48], P < 0.001) and 3 months (SMD: 0.50 [-0.96; −0.04], P = 0.032), but not at 6 or 12 months. No significant differences were found in the risk for new vertebral compression fractures between both groups (odds ratio (OR): 1.36 [0.51; 3.64], P = 0.54). According to the GRADE system, moderate certainty evidence indicates that BKP provides superior pain relief compared to conservative treatment at all time points from 1 to 12 months.

Conclusion

BKP showed superior pain reduction compared to conservative treatment from 1 to 12 months and improved disability at 1 and 3 months, with moderate certainty evidence.
背景骨质疏松性椎体压缩性骨折(OVCF)是一种常见病,通常会使人衰弱,严重影响生活质量和医疗成本。虽然骨折后初期通常会采取保守治疗,但有些患者会出现保守治疗无效的剧烈疼痛。在这种情况下,球囊椎体成形术(BKP)等微创椎体增量手术提供了一种替代方法,但与保守治疗相比,BKP 的益处仍不明确。目的 评估 BKP 与保守治疗相比,对疼痛型 OVCF 患者的疼痛、生活质量和功能的有效性。主要结果BKP术后12个月疼痛改善情况。次要结果功能改善情况、不良事件和椎体高度恢复情况。方法本分析包括随机对照试验和前瞻性比较研究,其中至少有100名参与者报告了BKP治疗OVCFs后的疼痛结果。采用标准工具对偏倚风险进行评估,并采用推荐、评估、发展和评价分级法(GRADE)对证据的确定性进行评价。结果BKP在1个月时的疼痛减轻效果优于保守治疗(平均差(MD):2.32[-3.65;-0.99],P <0.001)、3 个月(MD:1.19 [-2.14;-0.24],P = 0.014)、6 个月(MD:1.34 [-2.65;-0.04],P = 0.044)和 12 个月(MD:1.11 [-1.96;-0.26],P = 0.029)时,BKP 的疼痛减轻效果优于保守治疗(平均差异(MD):2.1个月和3个月时的残疾改善效果显著(标准化平均差(SMD):1.08 [-1.67; -0.48],P <0.001)(SMD:0.50 [-0.96; -0.04],P = 0.032),但6个月和12个月时的改善效果不明显。两组患者新发椎体压缩性骨折的风险无明显差异(几率比(OR):1.36 [0.51; 3.64],P = 0.54)。根据 GRADE 系统,中度确定性证据表明,与保守治疗相比,BKP 在 1 至 12 个月的所有时间点上都能更好地缓解疼痛。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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