股骨颈系统与空心钉联合内侧钢板治疗中青年股骨颈骨折的前瞻性多中心随机对照试验
Femoral neck system versus cannulated screws combined with medial plate for femoral neck fractures in young and middle-aged patients: a prospective multicenter randomized controlled trial.
作者信息
Wen Mingyu, Wang Shengying, Wang Lihua, Wang Yuhai, Dai Shiyou, Liu Wen, Fan Xiao
机构信息
Qingdao University, Qingdao, 266011, China.
Qingdao Municipal Hospital, No.1 Jiaozhou Road, Qingdao, 266011, China.
出版信息
J Orthop Surg Res. 2025 Jun 3;20(1):559. doi: 10.1186/s13018-025-05972-0.
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 .
背景
股骨颈系统（FNS）和带内侧钢板的空心螺钉（CS带内侧钢板）都是近年来常用于股骨颈骨折的内固定方法。对于中青年股骨颈骨折患者，哪种是更好的选择存在争议。本研究的目的是首次通过前瞻性多中心随机对照试验比较FNS和CS带内侧钢板对中青年股骨颈骨折患者的临床效果。
方法
将18至65岁的股骨颈骨折患者分为FNS固定组和CS带内侧钢板固定组，随访2年。主要结局包括骨折骨愈合率和Harris髋关节评分。次要结局包括Garden对线指数、手术数据、Barthel指数、视觉模拟评分（VAS）、步态分析以及随访期间的并发症。采用多元线性回归和逻辑回归进行统计分析。
结果
最终分析了FNS组的165例患者和CS带内侧钢板组的166例患者。两组在骨愈合率、Garden对线指数、Barthel指数、步态分析方面无统计学差异。FNS组术后3个月时Harris髋关节评分更高（P<0.05），手术数据包括手术时间、术中出血量和透视次数更低（P<0.001），术后1个月时VAS更低（P<0.05），但在3、6、12和24个月时无显著差异。除了髋内翻发生率在FNS组更高（P<0.05）外，两组并发症发生率无统计学差异。
结论
对于中青年股骨颈骨折患者，FNS和CS联合内侧钢板均有效。
试验注册
ChiCTR2100042960，于2021年2月1日注册，http://www.chictr.org.cn 。
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