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

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 Overview

• Status: Not yet recruiting
• Conditions: Prosthetic-joint Infection
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

• Study Contact: Name: Ahmed Sallam AboElazaiem, bachelor's; Phone Number: 01005732964; Email: ahmedsallam2020159@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1 diseased group(infected); 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	Procedure: bipolar hemiarthroplasty; bipolar hemiarthroplasty for neck femur fracture
group 2 : control group (normal ); no infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur	Procedure: bipolar hemiarthroplasty; bipolar hemiarthroplasty for neck femur fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of early infection after bipolar hemiarthroplasty	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	4 weeks postoperative
risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age	Age in years	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters :sex	male or female	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis.	present or not	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision)	present or not	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption	yes or no	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection).	present or no	preoperative evaluation 1 week
risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .	in hours	at time of operation
risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion.	yes or no	at time of operation
risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.	time in days	1 week postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Disease Attributes; Femoral Fractures; Hip Injuries; Hip Fractures; Infections; Communicable Diseases; Femoral Neck Fractures
• Other Study ID Numbers: Sallam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No