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Open Reduction and Internal Fixation of Humeral Midshaft Fracture: Anterior Versus Posterior Plate Fixation

2026年8月16日 更新者:Dr Jahanzaib Ramay
About 13 out of 10,000 patients get a humeral shaft fracture each year, accounting for 1.0-3.0% of all fractures. The central part of the humerus is where 60% of all humeral fractures occur. A midshaft humerus fracture typically happens because of a direct impact to the upper arm. Trauma, such as falls, motor vehicle accidents, or motorcycle accidents, is the most common cause of fractures. Internally fixing humeral shaft fractures is often accomplished by a variety of surgical techniques. Usually, the posterior technique is used to repair distal and mid-shaft fractures. However, the posterior technique necessitates lateral or prone stance. The aim of this study comparing the outcomes of internal fixation and open reduction of humeral midshaft fractures utilizing anterior and posterior plate fixation. We want to conduct this study to get evidence to confirm whether which approach is more appropriate and more successful in such fractures. Moreover, the findings of this research could profoundly influence clinical outcomes by guiding orthopedic surgeons in their decision-making for management of humeral midshaft fracture.

研究概览

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Punjab Province
      • Sāhīwāl、Punjab Province、巴基斯坦、57450
        • 招聘中
        • Sahiwal Teaching Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Presenting with humeral midshaft fracture (presence of fracture in the middle part or center of humerus )

Exclusion Criteria:

  • Patients with pathological or open fractures, concomitant fractures or ligament or tendon ruptures of elbow or shoulder joints (on clinical examination)
  • Patients presented after 14 days of injury, partial or complete disability of the elbow or shoulder joint on the affected side before injury
  • Previous surgical procedure on same side
  • Presence of neurovascular complications
  • Apparent dementia or other psychological problems

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group A, 75 Participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
In group A, participants will undergo ORIF by using anterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.
有源比较器:Group B participants
After getting approval from ethical review board. Written informed consent will be taken. The participants will be randomly assigned two groups using lottery method. In group B, 75 Participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months. After 3 months, plain x-ray will be done to assess the bone union . Patients will also be examined for ASES score by researcher and presence of postoperative radial nerve palsy will also be evaluated. All the data will be recorded in Performa.
In group B, participants will undergo ORIF by using posterior approach for plate fixation. Operative time will be noted. After surgery, patients will be shifted to post-surgical orthopedic wards and will be discharged from there. All patients will be followed-up in OPD for 3 months.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Operative time
大体时间:3 Months
It will be assessed by using in terms of minutes required to perform surgery from time of incision given in the skin until closure of skin with stitches.
3 Months
Bone union
大体时间:3 Months
It will be labeled if there is detectable callus bridge or at least three visible cortices on radiographs
3 Months
American Shoulder and Elbow Surgeons Score (ASES)
大体时间:3 Months
It will be assessed after 3 months of surgery
3 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月17日

初级完成 (估计的)

2026年8月17日

研究完成 (估计的)

2026年8月17日

研究注册日期

首次提交

2026年8月16日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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