RecruitingOBSERVATIONAL

A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)

This study, called "BASE," is looking into the best way to detect infections in people who have had shoulder or elbow joint replacement surgery. Sometimes, these joints can get infected, leading to the need for another (revision) operation. Doctors often use a needle to draw fluid from the joint (called aspiration) to check for germs, but they can also take a small tissue sample during surgery (called biopsy). This research aims to compare how accurate these two methods are at finding infections. Understanding which test works best will help doctors decide on the right treatment plan earlier, potentially leading to better outcomes for patients undergoing revision shoulder or elbow surgery.

At a glance

Status

Recruiting

Sponsor

Wrightington, Wigan and Leigh NHS Foundation Trust

Enrolment target

244

Start

20 Mar 2024

Estimated completion

01 Sep 2028

Periprosthetic Joint Infection

What is this study about?

When someone has a joint replacement, like in their shoulder or elbow, it can sometimes get infected. This type of infection, called a Periprosthetic Joint Infection (PJI), is a serious problem and is one of the main reasons why people need a second operation to fix or replace the joint again. Catching these infections early and accurately is really important for successful treatment, but it can be tricky for doctors to diagnose.

The BASE study aims to compare two main ways doctors try to find these infections: taking a fluid sample from the joint with a needle (called aspiration) and taking a small piece of tissue during surgery (called a biopsy). Doctors already know that aspiration can help identify the types of germs causing an infection and how to treat them with antibiotics before surgery. However, studies have mainly looked at aspiration for hip and knee replacements. We don't yet have enough information on how well it works for shoulder and elbow replacements, where different types of germs might be involved.

This research is important because it will fill a knowledge gap. By understanding if aspiration is a reliable test for shoulder and elbow infections, doctors can make better decisions about treatment. This could lead to more effective care, potentially reducing the need for multiple surgeries or stronger antibiotics, and ultimately, improving the health and recovery for people needing revision shoulder or elbow surgery.

Key takeaways

The study compares two ways to detect infection in shoulder and elbow joint replacements.
It aims to find out if taking fluid with a needle (aspiration) is as good as taking tissue (biopsy).
This research could help doctors diagnose infections better and earlier for future patients.
Participation involves allowing your test results to be used for research, not extra procedures.
The study focuses on common infections in shoulder and elbow joints.

Who may be eligible?

To join this study, you must be at least 18 years old and be having a second (revision) operation on your shoulder or elbow joint replacement. This includes if you've had a total shoulder replacement, a partial shoulder replacement, a reverse shoulder replacement, or any type of elbow joint replacement.

You cannot take part if you refuse to give your permission, or if you've been taking antibiotics within two weeks before the planned fluid sample or tissue sample. Pregnant individuals also cannot join, and if you're already in another research study that involves similar treatments, you might not be able to participate unless specifically approved by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a second operation on your shoulder or elbow joint replacement?
Have you stopped taking antibiotics at least two weeks before your planned fluid or tissue sample?
Are you not pregnant?
Are you willing to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

The study aims to compare diagnostic methods which would likely be part of your normal care in any case. Taking part would involve consenting to the study and allowing the research team to compare the results from the fluid sample (aspiration) and the tissue sample (biopsy) that your doctors would normally take. There are no additional visits or medications involved specifically for this study. The total duration of your participation would be until the results of these diagnostic tests are analysed in relation to your original operation.

Potential risks and benefits

There are no direct medical benefits from taking part in this study, but the information found could help improve diagnosis and treatment for future patients with shoulder and elbow joint replacement infections. There are no additional planned medical risks beyond those typically associated with the standard medical procedures (aspiration and biopsy) that you would likely undergo anyway. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Verified postcode
Wigan, United Kingdom· Recruiting

Common questions

What is a 'revision shoulder or elbow arthroplasty'?

This is a second operation to fix or replace an artificial shoulder or elbow joint that was put in before.

What is 'PJI'?

PJI stands for Periprosthetic Joint Infection, which is an infection around an artificial joint.

What are 'aspiration' and 'biopsy'?

Aspiration is when doctors use a needle to take fluid from your joint. A biopsy is when they take a tiny piece of tissue, often during surgery.

Will taking part in this study change my treatment?

No, this study is about comparing diagnostic tests. Your medical care will continue as planned by your doctors, based on what's best for you.

Do I have to do anything extra if I join?

You just need to give your permission for the study team to use the results from the usual tests your doctors order. There are no extra appointments or treatments for the study itself.

How to find out more

Adam Watts

adam.c.watts@wwl.nhs.uk 01257 256259 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.