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Low-Intensity Pulsed Ultrasound Versus Sham in the Treatment of Operatively Managed Scaphoid Nonunions: The SNAPU Randomized Controlled Trial.
The Journal of Bone & Joint Surgery ( IF 4.4 ) Pub Date : 2024-07-01 , DOI: 10.2106/jbjs.23.00783
Neil J White 1, 2 , Ethan D Patterson 2, 3 , Gurpreet S Dhaliwal 1, 2 , Kevin A Hildebrand 1, 2 ,
Affiliation  

UPDATE This article was updated on September 4, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. In the Note listing the members of the Wrist and Elbow Research Group of Canada, the text that had read "Thomas T. Goetz, MD, FRCSC" now reads "Thomas J. Goetz, MD, FRCSC". BACKGROUND The primary goal after open reduction and internal fixation of an established scaphoid nonunion is to achieve union. Low-intensity pulsed ultrasound (LIPUS) has been reported to increase the rate of union and to decrease the time to union for multiple fractures and nonunions in clinical and animal models. The evidence for LIPUS in the treatment of scaphoid nonunion, however, is sparse. The aim of this study was to assess whether active LIPUS (relative to sham LIPUS) accelerates the time to union following surgery for scaphoid nonunion. METHODS Adults with a scaphoid nonunion indicated for surgery were recruited for a multicenter, prospective, double-blinded randomized controlled trial. After surgery, patients self-administered activated or sham LIPUS units beginning at their first postoperative visit. The primary outcome was the time to union on serial computed tomography (CT) scans starting 6 to 8 weeks postoperatively. Secondary outcomes included patient-reported outcome measures, range of motion, and grip strength. RESULTS A total of 142 subjects completed the study (69 in the active LIPUS group and 73 in the sham group). The average age was 27 years, and the cohort was 88% male. There was no difference in time to union (p = 0.854; hazard ratio, 0.965; 95% confidence interval, 0.663 to 1.405). Likewise, there were no differences between the active LIPUS and sham groups with respect to any of the secondary outcomes, except for wrist flexion at baseline (p = 0.008) and at final follow-up (p = 0.043). CONCLUSIONS Treatment with LIPUS had no effect on reducing time to union in patients who underwent surgical fixation of established scaphoid nonunions. LEVEL OF EVIDENCE Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

中文翻译:


低强度脉冲超声与假手术治疗手舟状骨骨不连:SNAPU 随机对照试验。



更新本文于 2024 年 9 月 4 日更新,原因是之前的错误,该错误是在文章的初步版本发布到网上后发现的。在列出加拿大腕肘研究小组成员的注释中,原来的文字为“Thomas T. Goetz, MD, FRCSC”,现在改为“Thomas J. Goetz, MD, FRCSC”。背景技术已形成的舟状骨骨不连切开复位内固定后的主要目标是实现愈合。据报道,在临床和动物模型中,低强度脉冲超声 (LIPUS) 可以提高多发性骨折和骨不连的愈合率并缩短愈合时间。然而,LIPUS 治疗舟骨骨不连的证据很少。本研究的目的是评估活性 LIPUS(相对于假 LIPUS)是否能加速舟状骨骨不连手术后的愈合时间。方法 招募患有需要手术的舟状骨骨不连的成年人参加一项多中心、前瞻性、双盲随机对照试验。手术后,患者在第一次术后就诊时开始自行施用激活或假 LIPUS 装置。主要结果是术后 6 至 8 周开始连续计算机断层扫描 (CT) 扫描的愈合时间。次要结果包括患者报告的结果测量、运动范围和握力。结果 共有 142 名受试者完成了研究(活性 LIPUS 组 69 名,假手术组 73 名)。平均年龄为 27 岁,队列中 88% 为男性。愈合时间没有差异(p = 0.854;风险比,0.965;95% 置信区间,0.663 至 1.405)。 同样,除了基线时 (p = 0.008) 和最终随访时 (p = 0.043) 的腕部屈曲之外,活性 LIPUS 组和假手术组之间在任何次要结果方面都没有差异。结论 LIPUS 治疗对缩短舟骨骨不连手术固定患者的愈合时间没有影响。证据级别 治疗级别 I。有关证据级别的完整描述,请参阅作者须知。
更新日期:2024-07-01
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