Knee Arthritis OsteoarthritisBEYOND-BMINCT07763535
Is BMI Outdated in TKA Patient Selection?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 of Knee Arthritis Osteoarthritis and Knee Replacement Arthroplasty, run by East Lancashire Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthritis Osteoarthritis, Knee Replacement Arthroplasty, BMI
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- Availability of a preoperative lateral knee X-ray to allow measurement of soft tissue thickness
Who cannot join
- 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
- Absence of a suitable preoperative lateral knee X-ray for measurement of soft tissue thickness
- Patients who have registered a National Data Opt-Out
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Knee Arthritis Osteoarthritis, Knee Replacement Arthroplasty, BMI, Regional Body Composition, Periprosthetic Infection
- Keywords
- Total Knee Replacement, Knee Arthritis, Regional anatomy, BMI, Periprosthetic infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from index procedure
Secondary outcomes (3)
BMI and risk of post-operative infection
To assess the association between Body Mass Index (BMI) and postoperative infection following TKA
Measured: 12 months
BMI vs PTFT relationship
To evaluate the relationship between BMI and pre-tubercular subcutaneous fat thickness (PTFT)
Measured: 12 months
PTFT influence on return to theatre
To assess the association between PTFT and return to theatre (within 30 days and 1 year)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Hoggett, MBChB, FRCS, Study chair, East Lancashire NHS TrustCharles Hallett, MBBS, MRCS, Principal investigator, East Lancashire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763535
- Sponsor's protocol ID
- DEV144
- Other IDs
- 372419
- Acronym
- BEYOND-BMI
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07763535
- Acronym / sponsor ID
- BEYOND-BMI / DEV144
- Conditions
- Knee Arthritis Osteoarthritis, Knee Replacement Arthroplasty, BMI, Regional Body Composition, Periprosthetic Infection
- Keywords
- Total Knee Replacement, Knee Arthritis, Regional anatomy, BMI, Periprosthetic infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- Availability of a preoperative lateral knee X-ray to allow measurement of soft tissue thickness
Key exclusion criteria (6 listed)
- 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
- Absence of a suitable preoperative lateral knee X-ray for measurement of soft tissue thickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative periprosthetic joint infection
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.
3 secondary outcomes
BMI and risk of post-operative infection
Time frame: 12 months
BMI vs PTFT relationship
Time frame: 12 months
PTFT influence on return to theatre
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee Hoggett, MBChB, FRCS study chair
East Lancashire NHS Trust
Charles Hallett, MBBS, MRCS principal investigator
East Lancashire NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthritis Osteoarthritis and Knee Replacement Arthroplasty, run by East Lancashire Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Stephens (+447976152397, research.sponsorship@elht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative periprosthetic joint infection (time frame: 12 months from index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.