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

NCT06427772 | Not Yet Recruiting

• 1 other identifier: Sallam
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prosthetic-joint Infection

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

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

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

Interventions

bipolar hemiarthroplasty PROCEDURE

bipolar hemiarthroplasty for neck femur fracture

group 1 diseased group(infected); group 2 : control group (normal )

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Ahmed Sallam AboElazaiem, bachelor's

CONTACT

01005732964; ahmedsallam2020159@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05