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临床试验/NCT06427772
NCT06427772尚未招募不适用

Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur

Assiut University0 个研究点目标入组 74 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
主要终点
incidence of early infection after bipolar hemiarthroplasty

研究概览

简要总结

Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.

详细描述

Femoral neck fractures (FNF) have a significant incidence and a rising trend worldwide. FNF is associated with a high mortality and disability rate, decreasing the independence and quality of life for affected patients. Acute displaced intracapsular femoral neck fractures account for about half of all hip fractures, with the majority of these fractures in older patients being treated surgically with hip hemiarthroplasty(HA), total hip arthroplasty, or internal fixation. Hemiarthroplasty is also used to treat femoral neck nonunion, failed screw fixation, and pathological femoral neck fracture. The treatment aims are to reduce pain, allow early mobilization, and restore the patient's pre-injury level of function while limiting perioperative surgical and medical complications. Patients with FNF frequently undergo hemiarthroplasty to restore joint biomechanics. Two types of implants are used in hemiarthroplasty: monopolar and bipolar . The bipolar implants have a polyethylene bearing between the stem and head of the endoprosthesis, which allows the components to rotate. There are debatable findings and a lack of consensus on the optimal component for hemiarthroplasty. Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
  • Patients or their legal representative able to give informed consent.

排除标准

  • Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
  • Patients with a pathological fracture due to malignancy.

结局指标

主要结局

incidence of early infection after bipolar hemiarthroplasty

时间窗: 4 weeks postoperative

investigators will take all cases with bipolar hemiarthroplasty after femoral neck fracture then follow up them for 4 weeks. An infection was categorized as early, if it occurred within 4 weeks after surgery After that investigators will classify them to infected (disease group) and non infected (control group) and studying risk factor predisposing to early infection after HA. For diagnosis of infection : the presence of persistent discharge after 7 days

risk factor predisposing to early infection after HA.1-preoperative parameters :sex

时间窗: preoperative evaluation 1 week

male or female

risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection).

时间窗: preoperative evaluation 1 week

present or no

risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision)

时间窗: preoperative evaluation 1 week

present or not

risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption

时间窗: preoperative evaluation 1 week

yes or no

risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age

时间窗: preoperative evaluation 1 week

Age in years

risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis.

时间窗: preoperative evaluation 1 week

present or not

risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion.

时间窗: at time of operation

yes or no

risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.

时间窗: 1 week postoperative

time in days

risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .

时间窗: at time of operation

in hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Sallam Abo El-azaiem Mohamed

principal investigator

Assiut University

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