- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428760
Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk
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
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Cankaya
-
Ankara, Cankaya, Turkey, 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ashmehmetonut
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Hip Infection
-
Vastra Gotaland RegionGöteborg University; Halmstad University; RISE - Research Institutes of Sweden; CRC Medical AB and other collaboratorsUnknownHip Fractures | Surgical Site Infection | Orthopedic Disorder | Implant InfectionSweden
-
Soren OvergaardOdense University Hospital; Aarhus University Hospital; University of Copenhagen and other collaboratorsRecruitingTotal Hip Arthroplasty | Prosthetic-joint Infection | Fracture of Hip | Fracture AcetabularDenmark
-
University Hospital, ToursPfizer; International Clinical Trials AssociationUnknownEfficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection (LIZ-BONE)Hip Prosthetic Joint InfectionFrance, Spain, Italy
-
Istituto Ortopedico GaleazziUnknownHip Prosthesis Infection | Knee Prosthesis InfectionItaly
-
University Hospital, MontpellierTerminatedHip Osteoarthritis | Hip Prosthesis InfectionFrance
-
Istituto Ortopedico RizzoliUniversità degli studi di MessinaRecruitingHip Prosthesis InfectionItaly
-
University Hospital, GrenobleCompletedHip Prosthesis InfectionFrance
-
Groupe Hospitalier Diaconesses Croix Saint-SimonCompleted
-
University Hospital Bispebjerg and FrederiksbergUniversity Hospital Bispebjerg and Frederiksberg, Søren Overgaard, Professor... and other collaboratorsCompletedHip Prosthesis Infection
-
University Hospital, LinkoepingThe Swedish Research Council; Region ÖstergötlandRecruitingProsthetic Joint Infection | Osteoarthritis, Hip | Antibiotic Resistant Infection | Arthroplasty, Replacement, HipSweden