Li Qianchun, Chen Rigao, Yu Yang, Wang Xinling, Feng Xueya, Jiang Leiming, Chen Botao, Xin Peng, Li Tong, Shi Yin, Jian Qiang, Jiang Zhongchao, Fan Xiaohong
School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine.
Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.
Medicine (Baltimore). 2020 Oct 2;99(40):e22598. doi: 10.1097/MD.0000000000022598.
Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH.
Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling ("positive" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations.
To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH.
ChiCTR1900020888; Pre-results.
股骨头坏死（ONFH）是一种难治性疾病，早期诊断和治疗对于预防股骨头塌陷至关重要；然而，现有的治疗方案仍存在争议。本研究评估了体外冲击波疗法（ESWT）联合多次钻孔和髓内药物注射这种新型联合疗法的安全性和有效性，采用随机对照试验（RCT）模型，为早期ONFH患者提出一种替代治疗方法。
招募年龄在20至60岁、ARCO I-II期的股骨头坏死患者。12０名符合条件的参与者按1:1:1:1的比例随机分为四组：体外冲击波疗法联合多次钻孔和髓内药物注射（EMI组）、体外冲击波疗法（E组）、多次钻孔联合髓内药物注射（MI组）以及多次钻孔（“阳性”对照组；M组）。主要结局包括有效率、股骨头软骨下塌陷率、病变大小和骨髓水肿分级。次要结局包括Harris髋关节评分和视觉模拟量表。所有结局在筛查访视（基线）以及治疗和随访期间的计划时间间隔进行测量，并根据意向性分析亚组和符合方案分析亚组对疗效进行统计学分析。
探讨ESWT联合多次钻孔和髓内药物注射的临床疗效，为早期ONFH提供一种安全且更有效的治疗方法。
ChiCTR1900020888；预结果。
