Prosthetic-joint InfectionNCT06427772
Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
An observational study of Prosthetic-joint Infection, run by Assiut University.
Trial 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%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- bipolar hemiarthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
- Patients or their legal representative able to give informed consent.
Who cannot join
- Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
- Patients with a pathological fracture due to malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Prosthetic-joint Infection
- Being tested
- bipolar hemiarthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar hemiarthroplastyProcedure or surgery
bipolar hemiarthroplasty for neck femur fracture
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: bipolar hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks postoperative
risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age
Age in years
Measured: preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters :sex
male or female
Measured: 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
Measured: 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
Measured: preoperative evaluation 1 week
risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption
yes or no
Measured: 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
Measured: preoperative evaluation 1 week
risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .
in hours
Measured: 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
Measured: at time of operation
risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.
time in days
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sallam Abo El-azaiem Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427772
- Sponsor's protocol ID
- Sallam
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur
- ClinicalTrials.gov ID
- NCT06427772
- Acronym / sponsor ID
- Sallam
- Conditions
- Prosthetic-joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 diseased group(infected) | – | Procedure: bipolar hemiarthroplastythe 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 |
| group 2 : control group (normal ) | – | Procedure: bipolar hemiarthroplastyno infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with femoral neck fractures and treated by bipolar hemiarthroplasty.
- Patients or their legal representative able to give informed consent.
Key exclusion criteria (2 listed)
- Patients that received HA secondary to a failed internal fixation of a femoral neck fracture.
- Patients with a pathological fracture due to malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bipolar hemiarthroplastybipolar hemiarthroplasty for neck femur fracture | Procedure or surgery | group 1 diseased group(infected), group 2 : control group (normal ) |
Primary outcome
incidence of early infection after bipolar hemiarthroplasty
Time frame: 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 :Patient age
Time frame: preoperative evaluation 1 week
Age in years
risk factor predisposing to early infection after HA.1-preoperative parameters :sex
Time frame: preoperative evaluation 1 week
male or female
risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis.
Time frame: preoperative evaluation 1 week
present or not
risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision)
Time frame: preoperative evaluation 1 week
present or not
risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption
Time frame: preoperative evaluation 1 week
yes or no
risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection).
Time frame: preoperative evaluation 1 week
present or no
risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .
Time frame: at time of operation
in hours
risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion.
Time frame: at time of operation
yes or no
risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.
Time frame: 1 week postoperative
time in days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic-joint Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sallam AboElazaiem, bachelor's (01005732964, ahmedsallam2020159@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of early infection after bipolar hemiarthroplasty (time frame: 4 weeks postoperative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.