## Protocol Section
### Identification Module
**NCT ID:** NCT06428760

**Brief Title:** Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk

**Official Title:** The Effect of Preoperative Subcutaneous Trochanteric Fat Thickness and Trochanteric Soft Tissue Thickness on Postoperative Infection Risk in Patients Undergoing Hemiarthroplasty for Femoral Neck Fracture

#### Organization Study ID Info
**ID:** ashmehmetonut
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The effect of preoperative subcutaneous trochanteric fat thickness and trochanteric soft tissue thickness on postoperative infection risk in patients undergoing hemiarthroplasty for femoral neck fracture

**Detailed Description:** Obesity is a growing problem for healthcare systems and orthopaedic surgeons, with 29% of the adult population in the UK and 40% in the US affected by obesity. The most commonly used measure of obesity in healthcare is body mass index (BMI), and the World Health Organisation defines obesity as a BMI ≥ 30 kg/m2. Much of the arthroplasty literature has also focused on the use of BMI as a measure of obesity.

BMI-defined obesity is associated with an increased risk of perioperative complications (including infection and dislocation) in total hip arthroplasty. It has also been shown that there is a gradual increase in anaesthetic time, operative time and length of hospital stay as BMI increases in obese patients.

BMI is an imperfect measure because it does not take into account age, sex, race, fat distribution or muscle mass. Previous studies have shown that subcutaneous fat depth (FD) is an independent risk factor for wound infection in cervical and lumbar spine surgery and after laparotomy. It is not known whether increased subcutaneous fat and soft tissue mass are associated with an increased risk of complications after arthroplasty for femoral neck fractures.

The aim of this study was to investigate whether preoperative measurement of subcutaneous adipose tissue by radiography and computed tomography (CT) and muscle thickness in the gluteus medius/minus, gluteus maximus, anterior and medial compartments by computed tomography (CT) in femoral neck fractures correlate with infection rates at postoperative follow-up.

Hypothesis: In patients with high body mass index (BMI) with femoral neck fractures, the investigators believe that the relationship between increased subcutaneous adipose tissue on radiographs and CT sections and wound infection is as effective as the relationship between increased muscle thickness in the gluteus medius/minimus, gluteus maximus, anterior and medial compartments measured on CT sections and wound infection.

### Conditions Module

**Conditions:**

- Hip Infection

**Keywords:**

- subcutaneous trochanteric fat thickness

- infection

- femoral neck fracture

- soft tissue thickness

- obesity

- hemiarthroplasty

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Outcomes Module

#### Primary Outcomes

**Description:** The aim of this study was to evaluate the effect of peritrochanteric fat thickness and hip soft tissue parameters on postoperative wound infection in patients with femoral neck fracture.

Peritrochanteric fat thickness will be measured on preoperative radiographs along with sourcil to skin surface, greater trochanter tip to skin surface, and lateral greater trochanter to skin surface values.

Hip soft tissue assessment will be measured with the parameters of gluteus medius/minus, gluteus maximus, muscle thickness in the anterior and medial compartments on preoperative CT sections.

**Measure:** Effect of trochanteric fat and soft tissue

**Time Frame:** Pre-operative

**Description:** Wound infection is assessed using investigator dressings. In assessing surgical wound infection, an ASEPSIS score will be calculated for each patient to standardise for serous exudate, erythema, purulent exudate, deep tissue separation at the wound site.

**Measure:** Wound infection

**Time Frame:** First 3 months after surgery

#### Secondary Outcomes

**Description:** Hospital Length of Stay (LOS): Evaluate the duration of hospitalization following surgery, as prolonged LOS may be associated with increased risk of nosocomial infections including SSIs.

**Measure:** Hospital Length of Stay (LOS)

**Time Frame:** 1 months

**Description:** Mortality Rate: Assess mortality rates within a defined follow-up period following surgery, as postoperative infections, especially in vulnerable populations such as elderly patients with femoral neck fractures, may contribute to increased mortality.

Mortality risk is measured by the Charlson comorbidity index.

**Measure:** Mortality Rate

**Time Frame:** 6 months

**Description:** It has been suggested that there is a relationship between body mass index and post-operative wound infection. This index is measured in kg/m2 using the patient's height and weight.

**Measure:** Body Mass Index

**Time Frame:** Measured once preoperatively

**Description:** WBC, leukocyte, neutrophil, lymphocyte, albumin, CRP parameters will be evaluated in routine biochemistry scans

**Measure:** Biochemistry Scans

**Time Frame:** 1 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients over 65 years of age
* Femoral neck fractures
* Female patients
* Patients undergoing hemiarthroplasty

Exclusion Criteria:

* Patients younger than 65 years
* Male patients
* Patients with immunosuppressive conditions
* Intertrochanteric fractures
* Patients with revision surgery
* Pathological femoral neck fractures

**Minimum Age:** 65 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- OLDER_ADULT

**Study Population:** Female patients over 65 years of age who were admitted to our hospital with a history of a femoral neck fracture and who underwent hemiarthroplasty.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Ankara Bilkent City Hospital

**State:** Cankaya

**Zip:** 06800

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- 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: Femoral Neck Fractures

- 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

### 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
