Laser vs Lontophoresis in KOA
NCT07666061
Knee Arthritis Osteoarthritis
View Trial DetailsNCT Number: NCT07763535
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Total knee arthroplasty (TKA) is a highly effective intervention for end-stage osteoarthritis, providing significant improvements in pain and function. However, postoperative complications-particularly surgical site infection and periprosthetic joint infection (PJI)-remain among the most serious adverse outcomes. These complications are associated with substantial morbidity, the need for revision surgery, prolonged hospitalisation, and increased healthcare costs.
Obesity is a well-recognised risk factor for complications following TKA, and Body Mass Index (BMI) is widely used as a surrogate measure to guide patient selection. Across the NHS, BMI thresholds are commonly applied, often between 40 and 45, with the aim of reducing postoperative risk.
Despite its widespread use, BMI has well-documented limitations. It does not differentiate between fat and lean mass, nor does it account for fat distribution or regional anatomical variation. As such, BMI may not accurately reflect the local soft tissue characteristics at the surgical site, which are likely to influence wound healing and infection risk.
Recent studies have explored the role of regional soft tissue measurements, such as pre-tubercular subcutaneous fat thickness (PTFT), in predicting postoperative complications. Evidence suggests that increased subcutaneous tissue thickness over the proximal tibia may be associated with higher rates of wound complications and infection following TKA. However, existing studies are limited in number, and there is a lack of data within UK-based populations and NHS clinical practice.
While BMI is currently used as a primary tool for risk stratification in patients undergoing 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.
Postoperative infection following TKA is influenced by a combination of systemic and local patient factors. Body Mass Index is widely used as a surrogate marker of obesity and surgical risk; however, it is a crude measure that does not account for body composition, fat distribution, or regional anatomical variation.
PTFT represents a localized anatomical measurement of subcutaneous tissue overlying the proximal tibia, directly adjacent to the surgical field in TKA. Increased soft tissue thickness in this region may contribute to impaired wound healing through several mechanisms, including reduced tissue perfusion, increased dead space, prolonged operative time, and greater tension on wound closure.
Previous studies have demonstrated an association between increased subcutaneous tissue thickness and postoperative wound complications and infection following TKA. Unlike BMI, PTFT provides a patient-specific, anatomically relevant measurement that may better reflect the local biological environment influencing surgical outcomes.
This study aim to address this existing knowlege gap through adopting a retrospective observational approach to evaluate whether PTFT is a more accurate predictor of postoperative infection than BMI. By correlating radiographic measurements of PTFT with clinical outcomes, this study aims to address the limitations of BMI-based risk stratification and explore a more individualized approach to patient selection and risk assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months from index procedure
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.
Time frame: 12 months
To assess the association between Body Mass Index (BMI) and postoperative infection following TKA
Time frame: 12 months
To evaluate the relationship between BMI and pre-tubercular subcutaneous fat thickness (PTFT)
Time frame: 12 months
To assess the association between PTFT and return to theatre (within 30 days and 1 year)
Contact information is provided by the study sponsor or research team.
East Lancashire Hospitals NHS Trust
Other
Is BMI Outdated in TKA Patient Selection? Assessment of the Impact of Pre-tubercular Subcutaneous Tissue Thickness and the Risk of Postoperative Infection Following Total Knee Arthroplasty.
Acronym: BEYOND-BMI
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