• Dong Hu, Huawei Liu, Bei Yuan, Suxi Gu, Kai Xu, Fei Song, and Songhua Xiao.
• Department of Orthopaedics, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, P.R. China.
• Medicine (Baltimore). 2022 Oct 14; 101 (41): e30972.

AbstractThe first case of vertebral augmentation therapy in mainland China was reported in 2000. Since then, it has been widely used in China as a minimally invasive procedure to treat vertebral compression fractures. However, the characteristics of malpractice litigation involving vertebral augmentation therapy remains unclear. This study aims to analyze the characteristics of medical malpractice litigation involving vertebral augmentation therapy in mainland China for the past 10 years. Two online legal databases were queried for court verdicts involving vertebral augmentation therapy from Jan 2009 to Dec 2018 in mainland China. Each case file was then thoroughly reviewed and data pertaining to defendants, plaintiffs, case outcomes, allegations, and verdicts were abstracted, and descriptive analyses were performed. Level of evidence: LEVEL III. A total of 96 cases were enrolled for final analysis. The number of claims increased by five times during the past 10 years. More than two thirds (67.7%, n = 65) of the cases underwent percutaneous vertebroplasty, and 22.9% (n = 22) underwent percutaneous kyphoplasty, the rest (9.4%, n = 9) remained undefined. Paralysis was alleged in 35.4% of cases (n = 34), followed by significant physical injury (34.4%, n = 33). Cement leakage to spinal canal (44.8%, n = 43) is the most commonly cited reason for litigation, followed by incomplete informed consent (42.7%, n = 41), accidental dural puncture (20.8%, n = 20), unsatisfactory clinical outcome (18.8%, n = 18), and misdiagnosis (12.5%, n = 12). Acute pulmonary cement embolism (4.2%, n = 4), wrong-level vertebrae procedure (3.1%, n = 3) and postoperative infection (2.1%, n = 2) were less common causes for concern. Doctors successfully defended themselves only in 8 (8.3%) cases, which resulted in no indemnity payment. The rest 88 (91.7%) cases were closed with a mean verdict payout of 361,580 Yuan (51,654 US dollars). There is a quickly rising trend in the number of medical malpractice litigation involving vertebral augmentation therapy in China. Identifying the most common reasons for litigation and summarizing their characteristics may help decrease litigation rate and improve the patient experience.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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