RESUMO
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.