Abstract
BACKGROUND: Femoral neck system (FNS) and cannulated screws combined with medial plate (CS with medial plate) both are commonly used internal fixation for femoral neck fractures in recent years. There is a debate that which is the better choice for young and middle-aged patients with femoral neck fractures. The objective of the study is to compare clinical effects of FNS and CS with medial plate on young and middle-aged patients with femoral neck fractures by a prospective multicenter randomized controlled trial for the first time. METHODS: Patients between 18 and 65 years old with femoral neck fractures were allocated to FNS fixation and CS with medial plate fixation with 2 years follow-up. The primary outcomes included fracture bone union rate and Harris hip score. The secondary outcomes included Garden's alignment index, surgical data, Barthel index, visual analogue scale (VAS), gait analysis and complications during follow-up. Statistical analysis was performed by multiple linear regression and logistics regression. RESULTS: 165 patients in FNS group and 166 patients in CS with medial plate group were analyzed finally. There was no statistical difference in bone union rate, Garden's alignment index, Barthel index, gait analysis between two groups. The FNS group had a higher Harris hip score at 3 months after operation (P < 0.05), lower surgical data including operation time, intraoperative blood loss and fluoroscopy frequency (P < 0.001) and lower VAS at 1 month after operation (P < 0.05) than that of CS with medial plate group, but no significant difference at 3, 6, 12, and 24 months. There was no statistical difference in the incidence of complications between groups, except the incidence of coxa vara, which is higher in FNS group (P < 0.05). CONCLUSIONS: For young and middle-aged patients with femoral neck fractures, both FNS and CS combined with a medial plate are effective. TRIAL REGISTRATION: ChiCTR2100042960, registered 1 February 2021, http://www.chictr.org.cn .