Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk

Hip Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428760
• Other study ID #: ashmehmetonut
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Femoral Neck Fractures
• Hip Infection
• Infections

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of trochanteric fat and soft tissue	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.	Pre-operative
Primary	Wound infection	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.	First 3 months after surgery
Secondary	Hospital Length of Stay (LOS)	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.	1 months
Secondary	Mortality Rate	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.	6 months
Secondary	Body Mass Index	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.	Measured once preoperatively
Secondary	Biochemistry Scans	WBC, leukocyte, neutrophil, lymphocyte, albumin, CRP parameters will be evaluated in routine biochemistry scans	1 months