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Could a simple X-Ray measurement outperform BMI in knee surgery safety?

NCT ID NCT07763535

Knowledge-focused Sponsor: East Lancashire Hospitals NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study investigates whether the thickness of fat over the shin bone, measured on a standard knee X-ray, is a better predictor of infection after total knee replacement than Body Mass Index (BMI). Researchers will review data from 400 adults who had knee replacement surgery, comparing infection rates within 12 months against both BMI and this fat measurement. The goal is to see if this simple measurement could help doctors make fairer, more personalized decisions about who is suitable for surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If fat thickness proves a better predictor, it could lead to fairer, more personalized decisions about who is safe for knee replacement surgery.
What could go wrong
This is an observational study, so it can only show links, not cause and effect. The results may not apply beyond the specific hospitals and time period studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee periprosthetic joint infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BMI Knee arthritis osteoarthritis Knee replacement arthroplasty Periprosthetic infection Regional body composition

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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