## Protocol Section
### Identification Module
**NCT ID:** NCT06427772

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Sallam
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Ahmed Sallam Abo El-azaiem Mohamed

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Prosthetic-joint Infection

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Procedure: bipolar hemiarthroplasty

**Label:** group 1 diseased group(infected)

#### Arm Group 2

**Description:** no infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur

**Intervention Names:**

- Procedure: bipolar hemiarthroplasty

**Label:** group 2 : control group (normal )

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group 1 diseased group(infected)

- group 2 : control group (normal )

**Description:** bipolar hemiarthroplasty for neck femur fracture

**Name:** bipolar hemiarthroplasty

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** incidence of early infection after bipolar hemiarthroplasty

**Time Frame:** 4 weeks postoperative

**Description:** Age in years

**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age

**Time Frame:** preoperative evaluation 1 week

**Description:** male or female

**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :sex

**Time Frame:** preoperative evaluation 1 week

**Description:** present or not

**Measure:** 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

**Description:** present or not

**Measure:** 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

**Description:** yes or no

**Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption

**Time Frame:** preoperative evaluation 1 week

**Description:** present or no

**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).

**Time Frame:** preoperative evaluation 1 week

**Description:** in hours

**Measure:** risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time .

**Time Frame:** at time of operation

**Description:** yes or no

**Measure:** 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

**Description:** time in days

**Measure:** risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days.

**Time Frame:** 1 week postoperative

### Eligibility Module

**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.

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ahmedsallam2020159@gmail.com

**Name:** Ahmed Sallam AboElazaiem, bachelor's

**Phone:** 01005732964

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006620

- Term: Hip Fractures

- ID: D000005264

- Term: Femoral Fractures

- ID: D000050723

- Term: Fractures, Bone

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M8403

- Name: Femoral Neck Fractures

- Relevance: HIGH

- As Found: Fracture Neck of Femur

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M9696

- Name: Hip Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

- ID: T4756

- Name: Prosthetic Joint Infection

- Relevance: HIGH

- As Found: Prosthetic Joint Infection

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000005265

- Term: Femoral Neck Fractures

### Misc Info Module

- Version Holder: 2024-05-31
