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压缩支撑与非轴向螺钉固定治疗青壮年垂直型股骨颈骨折:一项前瞻性、随机对照试验。

Compressive buttress compared with off-axial screw fixation for vertical femoral neck fractures in young adults: a prospective, randomized controlled trial.

机构信息

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200233, China.

Shanghai Sixth People's Hospital, National Center for Orthopaedics, Shanghai, 200233, China.

出版信息

J Orthop Surg Res. 2024 Jan 6;19(1):42. doi: 10.1186/s13018-023-04493-y.

DOI:10.1186/s13018-023-04493-y
PMID:38184587
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10771671/
Abstract

BACKGROUND

To compare the clinical outcomes of compressive buttress screw (CBS) fixation, a novel screw fixation strategy, to off-axial screw fixation (off-axial partial threaded cannulated screw, OPTCS) for vertical femoral neck fractures (FNFs) in young adults.

METHODS

A total of 146 adults younger than 55 years old with high-energy Pauwels type III FNFs were randomized to receive CBS fixation or OPTCS fixation. Primary outcomes were complication rates, including fixation failure, fracture nonunion, and avascular necrosis of the femoral head (ANFH) at 24 months after treatment. Fixation loosening, femoral neck shortening and varus collapse, patient function and quality of life using the Harris hip score (HHS), and EuroQol-5 dimensional-5 levels (EQ-5D-5L) questionnaire (including EQ-5D-5L and EQ-VAS) were assessed as secondary outcomes at 24 months.

RESULTS

CBS and OPTCS fixation groups were similar with regard to demographics at baseline. At 24 months, patients in the CBS fixation cohort had a significantly lower rate of fixation failure (10.5% vs. 25.0%, p = 0.041) and fracture nonunion (1.8% vs. 18.3%, p = 0.003) compared with patients who received OPTCS fixation. There was no difference in rate of ANFH (7.0% vs. 11.7%, p = 0.389) between groups. Additionally, patients managed with CBS fixation showed significantly less fixation loosening (19.3% vs. 58.3%, p < 0.001), less severe femoral neck shortening and varus collapse (10.5% vs. 25.0%, p = 0.007), higher HHS (93 vs. 83, p = 0.001) and more excellent grade (68.4% vs. 36.7%, p = 0.008), higher EQ-5D-5L (0.814 vs, 0.581, p < 0.001) and EQ-VAS (85 vs. 80, p = 0.002).

CONCLUSION

CBS screw fixation confers significantly lower complication rate in addition to higher functional and quality of life outcomes for young adults with high-energy FNF compared with OPTCS fixation.

TRIAL REGISTRATION

This prospective, randomized controlled trial was approved by the institutional review board of our center, Ethics Committee of Shanghai sixth people's Hospital, and registered at www.chictr.org.cn (Approval Number: ChiCTR1900026283; Registered 29 September 2019-Retrospectively registered, https://www.chictr.org.cn/showproj.html?proj=43164 ).

摘要

背景

比较压迫性支撑螺钉(CBS)固定与非轴向螺钉固定(非轴向部分螺纹空心钉,OPTCs)治疗年轻成人垂直股骨颈骨折(FNFs)的临床效果。

方法

共纳入 146 名年龄小于 55 岁、高能量 Pauwels Ⅲ型 FNFs 的患者,随机接受 CBS 固定或 OPTCS 固定。主要结局为治疗后 24 个月时的并发症发生率,包括固定失败、骨折不愈合和股骨头缺血性坏死(ANFH)。次要结局为固定松动、股骨颈缩短和内翻塌陷、患者功能和生活质量(采用 Harris 髋关节评分(HHS))和 EuroQol-5 维度-5 水平(EQ-5D-5L)问卷(包括 EQ-5D-5L 和 EQ-VAS),均在 24 个月时进行评估。

结果

CBS 和 OPTCS 固定组患者在基线时的人口统计学特征相似。在 24 个月时,CBS 固定组的固定失败率(10.5% vs. 25.0%,p=0.041)和骨折不愈合率(1.8% vs. 18.3%,p=0.003)明显低于 OPTCS 固定组。两组的 ANFH 发生率无差异(7.0% vs. 11.7%,p=0.389)。此外,CBS 固定组的固定松动发生率明显更低(19.3% vs. 58.3%,p<0.001),股骨颈缩短和内翻塌陷程度更轻(10.5% vs. 25.0%,p=0.007),HHS 更高(93 分 vs. 83 分,p=0.001)和优良率更高(68.4% vs. 36.7%,p=0.008),EQ-5D-5L 更高(0.814 分 vs. 0.581 分,p<0.001)和 EQ-VAS 更高(85 分 vs. 80 分,p=0.002)。

结论

与 OPTCS 固定相比,CBS 螺钉固定可显著降低年轻成人高能 FNF 的并发症发生率,并提高功能和生活质量。

试验注册

这是一项前瞻性、随机对照试验,得到了我院机构审查委员会、上海市第六人民医院伦理委员会的批准,并在 www.chictr.org.cn 上注册(注册号:ChiCTR1900026283;注册日期:2019 年 9 月 29 日-回溯性注册,https://www.chictr.org.cn/showproj.html?proj=43164)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8dad/10771671/8c32dacc8e4e/13018_2023_4493_Fig6_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8dad/10771671/960d5d34b5c5/13018_2023_4493_Fig1_HTML.jpg
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