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Pinloc或汉森针:一项针对439例股骨颈骨折患者的多中心随机对照研究。

Pinloc or Hansson pins: a multicenter, randomized controlled study of 439 patients treated for femoral neck fractures.

作者信息

Åberg Henrik, Kalland Kristine, Jonsson Kenneth B, Johansson Torsten

机构信息

Department of Orthopedic Surgery, Institution of Surgical Sciences, Uppsala University, Uppsala, Sweden.

Department of Orthopedic Surgery, Nyköping Hospital, Nyköping, Sweden.

出版信息

OTA Int. 2023 Sep 22;6(4):e282. doi: 10.1097/OI9.0000000000000282. eCollection 2023 Dec.

Abstract

OBJECTIVES

To compare the recently developed Hansson Pinloc system, which features 3 cylindrical parallel pins with hooks connected through a fixed-angle interlocking plate, with the Hansson Pin System (2 hook pins) for the treatment of femoral neck fractures.

DESIGN

One hundred fourteen patients with displaced femoral neck fractures and 325 patients with nondisplaced fractures from 9 orthopaedic centers were randomized to either Hansson Pinloc system or Hansson Pin System and followed for 2 years or until death. Age at inclusion was 50 years or older.

MAIN OUTCOME MEASUREMENTS

The primary outcome was failure (defined as early displacement, nonunion, symptomatic avascular necrosis, or deep infection). Secondary outcomes included revision surgery, Timed Up and Go (TUG) test and patient-reported outcome measures (PROMs: EQ-5D and WOMAC).

RESULTS

For nondisplaced fractures, the incidence of failure was 14% (23/169) in the Pinloc group and 16% (25/156) in the Hansson group. For displaced fractures, the analysis was stratified by age. Patients aged 50-69 years with displaced fractures showed a 2-year failure rate of 44% (17/39) in the Pinloc group versus 44% (16/36) in the Hansson group. For patients 70 years or older with displaced fractures, 33% (7/21) in the Pinloc group versus 22% (4/18) in the Hansson group failed. At 3 and 12 months, no clinically significant differences between treatment groups were found for EQ-5D-3L, WOMAC, or for the TUG in any fracture type or age group.

CONCLUSIONS

There were no advantages for Pinloc in any of the studies aspects.

LEVEL OF EVIDENCE

摘要

目的

比较最近开发的汉森针锁系统(Hansson Pinloc system)与汉森针系统(Hansson Pin System)治疗股骨颈骨折的效果。汉森针锁系统的特点是有3根圆柱形平行针,通过一个固定角度的互锁板连接挂钩。

设计

来自9个骨科中心的114例移位型股骨颈骨折患者和325例非移位型骨折患者被随机分为汉森针锁系统组或汉森针系统组,并随访2年或直至死亡。纳入时年龄为50岁或以上。

主要观察指标

主要结局为失败(定义为早期移位、骨不连、有症状的缺血性坏死或深部感染)。次要结局包括翻修手术、定时起立行走(Timed Up and Go,TUG)测试以及患者报告的结局指标(PROMs:EQ-5D和WOMAC)。

结果

对于非移位型骨折,针锁组的失败发生率为14%(23/169),汉森组为16%(25/156)。对于移位型骨折,分析按年龄分层。50 - 69岁的移位型骨折患者中,针锁组的2年失败率为44%(17/39),汉森组为44%(16/36)。对于70岁及以上的移位型骨折患者,针锁组的失败率为33%(7/21),汉森组为22%(4/18)。在3个月和12个月时,任何骨折类型或年龄组的治疗组在EQ-5D-3L、WOMAC或TUG方面均未发现临床显著差异。

结论

在任何研究方面,针锁系统均无优势。

证据级别

1级。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad95/10516382/c2599cc214fa/oi9-6-e282-g001.jpg

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