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股骨和胫骨干骨折的静态与动态髓内钉固定:一项双盲随机临床试验

Static versus dynamic intramedullary nailing for femoral and tibial shaft fractures: a double-blind, randomized clinical trial.

作者信息

Najafi Arvin, Chaghamirzayi Pouria, Hadavi Dorsa, Najafi Pirasteh Monir, Sedighi Ali, Azarsina Salman

机构信息

Shahid Madani Hospital, Alborz University of Medical Sciences, Karaj, Iran.

Clinical Research Development Unit of Shahid Madani Hospital, Alborz University of Medical Science, Karaj, Iran.

出版信息

Ann Med Surg (Lond). 2025 Mar 27;87(4):2006-2013. doi: 10.1097/MS9.0000000000003108. eCollection 2025 Apr.

Abstract

BACKGROUND

The optimal fixation method for femur and tibia shaft fractures remains debated. Both static intramedullary nailing (SIMN) and dynamic intramedullary nailing (DIMN) are commonly used. This study aims to compare the efficacy of SIMN versus DIMN in promoting fracture healing.

METHODS

This double-blind, randomized clinical trial was conducted from June 2022 to March 2024. Fifty-two people with single transverse or short oblique femur or tibia fractures were randomly put into two groups, SIMN and DIMN. Each group had 26 people. The primary outcome was time to union, and secondary outcomes included surgical and post-surgical complications. Statistical analysis was performed using SPSS version 28.0.

RESULTS

The study included 52 participants (22 men and 30 women), with a mean age of 54.48 (SD 11.31). The median time to union in the DIMN group was significantly lower than in the SIMN group (20.5 (IQR 17-24) versus 24 (IQR 22-35), = 0.008). No statistical significance was observed in either group regarding nonunion, malunion, delayed union, and reoperation rates.

CONCLUSION

Dynamic intramedullary nailing (DIMN) significantly reduces the median time to union compared to static intramedullary nailing (SIMN) for femoral and tibial shaft fractures. Despite the shorter union time with DIMN, both techniques showed similar outcomes regarding nonunion, malunion, delayed union, and reoperation rates. These findings suggest that while DIMN may offer faster fracture healing, SIMN and DIMN are viable options depending on individual patient and clinical considerations.

摘要

背景

股骨干和胫骨干骨折的最佳固定方法仍存在争议。静态髓内钉固定(SIMN)和动态髓内钉固定(DIMN)都被广泛使用。本研究旨在比较SIMN与DIMN促进骨折愈合的疗效。

方法

本双盲随机临床试验于2022年6月至2024年3月进行。52例单发性横行或短斜行股骨干或胫骨干骨折患者被随机分为两组,即SIMN组和DIMN组。每组26人。主要结局指标为骨折愈合时间,次要结局指标包括手术及术后并发症。使用SPSS 28.0版进行统计分析。

结果

该研究纳入52名参与者(22名男性和30名女性),平均年龄为54.48岁(标准差11.31)。DIMN组的骨折愈合中位时间显著低于SIMN组(20.5(四分位间距17 - 24)对24(四分位间距22 - 35),P = 0.008)。两组在骨不连、畸形愈合、延迟愈合和再次手术率方面均未观察到统计学差异。

结论

对于股骨干和胫骨干骨折,与静态髓内钉固定(SIMN)相比,动态髓内钉固定(DIMN)显著缩短了骨折愈合的中位时间。尽管DIMN的愈合时间较短,但在骨不连、畸形愈合、延迟愈合和再次手术率方面,两种技术显示出相似的结果。这些发现表明,虽然DIMN可能使骨折愈合更快,但根据个体患者情况和临床考虑,SIMN和DIMN都是可行的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac2c/11981447/7cae76638d09/ms9-87-2006-g001.jpg

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Primary dynamic interlocking nail in femoral shaft fracture: A case series.
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