Is BMI Outdated in TKA Patient Selection?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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEast Lancashire Hospitals NHS Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Adults over 18 undergoing Primary Total Knee Replacement

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months from index procedure

Secondary outcomes

1

BMI and risk of post-operative infection

To assess the association between Body Mass Index (BMI) and postoperative infection following TKA

Time frame
12 months
2

BMI vs PTFT relationship

To evaluate the relationship between BMI and pre-tubercular subcutaneous fat thickness (PTFT)

Time frame
12 months
3

PTFT influence on return to theatre

To assess the association between PTFT and return to theatre (within 30 days and 1 year)

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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