About this trial
While Body Mass Index (BMI) is currently used as a primary tool for risk stratification in patients undergoing Total Knee Athroplasty(TKA), its limitations raise concerns regarding its accuracy and fairness in guiding surgical decision-making. In particular, reliance on BMI alone may lead to the exclusion of patients who could safely benefit from surgery, while failing to identify others at increased risk due to unfavourable local anatomical factors. Pre-tubercular subcutaneous fat thickness (PTFT) offers a simple, reproducible, and anatomically relevant measurement that directly reflects the soft tissue envelope at the operative site. As such may provide a more clinically meaningful assessment of infection risk than BMI. This study aims to evaluate the association between PTFT and postoperative infection following TKA. By doing so, it seeks to determine whether PTFT could serve as an adjunct or alternative risk stratification tool in clinical practice.
The findings of this study have the potential to inform a more individualized approach to patient selection and preoperative counselling, improving shared decision-making and resource utilisation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older at the time of surgery
Underwent primary total knee replacement surgery
Procedure performed at East Lancashire Hospitals NHS Trust (Burnley General Hospital or Royal Blackburn Hospital)
Surgery performed between 1 November 2023 and 30 November 2024
Disqualifiers
Patients who underwent revision knee replacement surgery
Patients who underwent partial (unicompartmental) knee replacement surgery
Patients aged under 18 years at the time of surgery
Primary procedure performed outside East Lancashire Hospitals NHS Trust
Trial population
Adults aged over 18 meeting the study criteria who have undergone a primary TKR at East Lancashire Hospital NHS Trust within the defined study period will be included in the study. Patients will be identified using a combination of OPCS codes for primary TKA, theatre logs and electronic operation records. All eligible adults withint the study period will be included for analysis.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Postoperative periprosthetic joint infection
The primary objective is to determine whether an increase in the thickness of the soft tissue (fat) over the front of the shin bone (known as pre-tubercular subcutaneous fat thickness) as measured on a lateral pre-operative x-ray is associated with an increased risk of postoperative infection within 12 months following primary total knee arthroplasty.
Secondary outcomes
BMI and risk of post-operative infection
To assess the association between Body Mass Index (BMI) and postoperative infection following TKA
BMI vs PTFT relationship
To evaluate the relationship between BMI and pre-tubercular subcutaneous fat thickness (PTFT)
PTFT influence on return to theatre
To assess the association between PTFT and return to theatre (within 30 days and 1 year)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: