Clinical trial NCT06427772: Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
Official title: Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prosthetic-joint Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Study Setting: Department of Orthopedic and Trauma Surgery, Assiut University.
* Study subjects:

  a. Inclusion criteria:
* Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
* Patients or their legal representative able to give informed consent. b. Exclusion criteria:
* Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
* Patients with a pathological fracture due to malignancy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: incidence of early infection after bipolar hemiarthroplasty
timeFrame: 4 weeks postoperative
measure: risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.1-preoperative parameters :sex
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis.
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision)
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection).
timeFrame: preoperative evaluation 1 week
measure: risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .
timeFrame: at time of operation
measure: risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion.
timeFrame: at time of operation
measure: risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.
timeFrame: 1 week postoperative
Secondary outcomes:
Other outcomes:
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Study officials:
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