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

Not yet recruiting

• Conditions: Prosthetic-joint Infection
• Interventions: Procedure: bipolar hemiarthroplasty

• Registration Number: NCT06427772
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 2 : control group (normal )	bipolar hemiarthroplasty	no infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur
group 1 diseased group(infected)	bipolar hemiarthroplasty	the presence of persistent discharge after 7 days diagnostic for early infection follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur study the risk factors in this group

Primary Outcome Measures

Name	Time	Method
incidence of early infection after bipolar hemiarthroplasty	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	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).	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)	preoperative evaluation 1 week	present or not
risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption	preoperative evaluation 1 week	yes or no
risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age	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.	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.	at time of operation	yes or no
risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.	1 week postoperative	time in days
risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .	at time of operation	in hours