CClinicalTrials.gg
Not yet recruitingNCT07763535BEYOND-BMIUpdated Aug 13, 2026

Is BMI Outdated in TKA Patient Selection?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

An observational study in Knee Arthritis Osteoarthritis, Knee Replacement Arthroplasty and BMI, sponsored by East Lancashire Hospitals NHS Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by East Lancashire Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Knee Arthritis Osteoarthritis
  • Knee Replacement Arthroplasty
  • BMI
  • Regional Body Composition
  • Periprosthetic Infection

Keywords

  • Total Knee Replacement
  • Knee Arthritis
  • Regional anatomy
  • BMI
  • Periprosthetic infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Inclusion criteria

  1. Adults aged 18 years or older at the time of surgery
  2. Underwent primary total knee replacement surgery
  3. Procedure performed at East Lancashire Hospitals NHS Trust (Burnley General Hospital or Royal Blackburn Hospital)
  4. Surgery performed between 1 November 2023 and 30 November 2024
  5. Availability of a preoperative lateral knee X-ray to allow measurement of soft tissue thickness

Exclusion criteria

Exclusion Criteria:

  1. Patients who underwent revision knee replacement surgery
  2. Patients who underwent partial (unicompartmental) knee replacement surgery
  3. Patients aged under 18 years at the time of surgery
  4. Primary procedure performed outside East Lancashire Hospitals NHS Trust
  5. Absence of a suitable preoperative lateral knee X-ray for measurement of soft tissue thickness
  6. Patients who have registered a National Data Opt-Out
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults over 18 undergoing Primary Total Knee Replacement

    This cohort includes adults undergoing Primary Total Knee Replacement within the defined study period meeting the exclusion and exclusion criteria. The end point is 12 months following index procedure with events of interest being periprosthetic joint infection.

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because the dataset contains potentially identifiable patient information collected under NHS approvals for the purposes of this study only. Participant consent for public data sharing was not obtained, and sharing individual-level data would be subject to UK data protection legislation, institutional information governance requirements, and sponsor approval.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07763535
Lead sponsor
East Lancashire Hospitals NHS Trust
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Aug 17, 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Michelle Stephens
Contact
research.sponsorship@elht.nhs.uk
+447976152397
Lee Hoggett, MBChB, FRCS
study chair · East Lancashire NHS Trust
Charles Hallett, MBBS, MRCS
principal investigator · East Lancashire NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion