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Garden I 型髋部骨折的保守治疗与手术治疗的随机对照试验方案。

Conservative versus surgical treatment for Garden I hip fracture: A randomized controlled trial protocol.

机构信息

Department of Orthopaedics, Zhenhai District People's Hospital of Ningbo, Zhejiang.

Department of Orthopaedics, the First People's Hospital of Jingzhou, Hubei, China.

出版信息

Medicine (Baltimore). 2020 Dec 24;99(52):e23378. doi: 10.1097/MD.0000000000023378.

Abstract

BACKGROUND

A femoral neck fracture (FNF) is one of the most destructive and familiar injuries encountered via the orthopedic surgeons. However, this is no guideline for the treatment of the Garden I hip fractures because the current evidence is limited from the poor study design and small sample size. The objective of our research is to compare the safety and effectiveness of the surgical treatment and conservative treatment in the non-displaced FNFs.

METHODS

This is a randomized trial, which will be implemented from December 2020 to December 2021. The experiment was granted through the Research Ethics Committee of the Zhenhai District People's Hospital of Ningbo (2014005). Hundred patients meet inclusion criteria and exclusion criteria are included. Patients who are eligible for the following conditions will be included: those over 75 years old with Garden I hip fractures diagnosed by CT or X-ray. Patients with the following conditions will be excluded: patients age under 75 years old, the avascular necrosis of the femoral head, pathological fracture, infection, former symptomatic hip pathology, the history of hip fracture, as well as the lower limb deformity. The primary outcome contains pain at 1 month, 3 months and 6 months and hip function at 1 month, 3 months and 6 months. Secondary outcome includes the life quality, mortality rate, complications such as deep venous thrombosis, pulmonary embolism.

RESULTS

Comparison of outcome indicators in 2 groups after conservative treatment or surgical treatment (Table).

CONCLUSION

The current trial will offer better evidence for the future treatment selection for Garden 1 FNFs for patients older than 75years old.

TRIAL REGISTRATION NUMBER

researchregistry6147.

摘要

背景

股骨颈骨折(FNF)是骨科医生最常见也是最具破坏性的损伤之一。然而,对于 Garden I 型髋部骨折,目前尚无治疗指南,因为现有证据受到研究设计不佳和样本量小的限制。我们的研究目的是比较非移位型 FNF 手术治疗与保守治疗的安全性和有效性。

方法

这是一项随机试验,将于 2020 年 12 月至 2021 年 12 月进行。该实验已获得宁波市镇海区人民医院伦理委员会的批准(2014005)。符合纳入标准和排除标准的 100 名患者被纳入研究。符合以下条件的患者将被纳入:年龄>75 岁,CT 或 X 线诊断为 Garden I 型髋部骨折。排除以下条件的患者:年龄<75 岁、股骨头缺血性坏死、病理性骨折、感染、既往有髋部症状性疾病、髋部骨折史、下肢畸形。主要结局包括 1 个月、3 个月和 6 个月时的疼痛以及 1 个月、3 个月和 6 个月时的髋关节功能。次要结局包括生活质量、死亡率、深静脉血栓形成、肺栓塞等并发症。

结果

保守治疗或手术治疗后两组患者的结局指标比较(表)。

结论

本试验将为 75 岁以上 Garden 1 FNF 患者的未来治疗选择提供更好的证据。

试验注册号

researchregistry6147。

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本文引用的文献

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Femoral neck shortening after internal fixation of Garden I fractures increases the risk of femoral head collapse.
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