Single versus dual Kirschner wires for closed reduction and intramedullary nailing of displaced fractures of the fifth metacarpal neck (1-2 KiWi): a randomized controlled trial

医学 髓内棒 破折号 随机对照试验 畸形愈合 外科 放射性武器 克氏针 固定(群体遗传学) 内固定 骨不连 人口 计算机科学 环境卫生 操作系统
作者
A. Eisenschenk,Romy Spitzmüller,Claas Güthoff,A. Obladen,Simon Kim,Esther Henning,Jenny E. Dornberger,Dirk Stengel,KiWi Investigators
出处
期刊:The bone & joint journal [British Editorial Society of Bone and Joint Surgery]
卷期号:101-B (10): 1263-1271 被引量:18
标识
DOI:10.1302/0301-620x.101b10.bjj-2019-0410.r1
摘要

Aims The aim of this study was to investigate whether clinical and radiological outcomes after intramedullary nailing of displaced fractures of the fifth metacarpal neck using a single thick Kirschner wire (K-wire) are noninferior to those of technically more demanding fixation with two thinner dual wires. Patients and Methods This was a multicentre, parallel group, randomized controlled noninferiority trial conducted at 12 tertiary trauma centres in Germany. A total of 290 patients with acute displaced fractures of the fifth metacarpal neck were randomized to either intramedullary single-wire (n = 146) or dual-wire fixation (n = 144). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire six months after surgery, with a third of the minimal clinically important difference (MCID) used as the noninferiority threshold. Secondary outcomes were pain, health-related quality of life (EuroQol five-dimensional questionnaire (EQ-5D)), radiological measures, functional deficits, and complications. Results Overall, 151/290 of patients (52%) completed the six months of follow-up, leaving 83 patients in the single-wire group and 68 patients in the dual-wire group. In the modified intention-to-treat analysis set, mean DASH scores six months after surgery were 3.8 (sd 7.0) and 4.4 (sd 9.4), respectively. With multiple imputation (n = 288), mean DASH scores were estimated at 6.3 (sd 8.7) and 7.0 (sd 10.0). Upper (1 - 2α)) confidence limits consistently remained below the noninferiority margin of 3.0 points in the DASH instrument. While there was a statistically nonsignificant trend towards a higher rate of shortening and rotational malalignment in the single wire group, no statistically significant differences were observed across groups in any secondary outcome measure. Conclusion A single thick K-wire is sufficient for intramedullary fixation of acute displaced subcapital fractures of the fifth metacarpal neck. The less technically demanding single-wire technique produces noninferior clinical and radiological outcomes compared with the dual-wire approach. Cite this article: Bone Joint J 2019;101-B:1263–1271
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