Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk

May 20, 2024 updated by: Ankara City Hospital Bilkent

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

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cankaya
      • Ankara, Cankaya, Turkey, 06800
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of trochanteric fat and soft tissue
Time Frame: Pre-operative

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
Wound infection
Time Frame: First 3 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay (LOS)
Time Frame: 1 months
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
Mortality Rate
Time Frame: 6 months

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
Body Mass Index
Time Frame: Measured once preoperatively
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
Biochemistry Scans
Time Frame: 1 months
WBC, leukocyte, neutrophil, lymphocyte, albumin, CRP parameters will be evaluated in routine biochemistry scans
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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