RecruitingInterventional

Fix or replace enhancing distal humerus fracture outcomes

This study is looking at two common ways to treat a broken elbow in people aged 60 and over. These breaks usually happen inside the elbow joint, causing pain and stiffness. The two treatments are: replacing part or all of the elbow joint with an artificial one (called elbow replacement), or fixing the broken bones with metal plates and screws (called internal fixation). Both treatments are already used in the UK, but doctors don't yet know which one is better at helping people recover fully. This study will compare them to find out, helping to improve future care for similar elbow injuries. Participants will be randomly assigned one of these surgeries and will fill out questionnaires over time to track their recovery.

At a glance

Status

Recruiting

Sponsor

Nottingham University Hospitals NHS Trust

Enrolment target

320

Start

27 May 2025

Estimated completion

01 Feb 2028

Intra-articular fracture of the distal humerus AO type B or C

What is this study about?

Every year, many adults in the UK break their elbow, especially older people. These serious breaks, specifically those inside the joint, can cause long-lasting pain and stiffness, making everyday tasks difficult. It's really important for healthcare professionals to know which treatment gives patients the best chance of getting back to their usual activities. This study aims to find the most effective treatment for these types of elbow fractures.

Currently, there are two main surgical options for older people with these breaks. One is called 'elbow replacement', where a surgeon replaces part or all of the damaged elbow joint with an artificial one made of metal and plastic. The other is called 'internal fixation' or 'repair', which involves carefully lining up the broken bones and holding them in place with metal plates and screws. Both of these operations are well-established and routinely performed in hospitals across the UK; they are not new or experimental.

However, doctors don't yet know which of these two widespread treatments leads to the best recovery and long-term results for patients. This study has been designed to compare them directly. By carefully looking at how people recover after each type of surgery, researchers hope to discover which method is more effective at reducing pain, improving movement, and helping people return to their normal lives. The findings from this study will help doctors make better decisions about care for future patients with similar elbow breaks.

Key takeaways

Compares two treatments for broken elbows in people aged 60+.
Aims to find out if elbow replacement or fixing with plates/screws is better.
Both treatments are standard, not experimental.
Participation involves random assignment to one surgery and completing questionnaires.
Information gathered will help improve future patient care.
You will receive standard NHS care regardless of participation.

Who may be eligible?

This study is looking for people aged 60 years or older who have broken their elbow, specifically a type of break that affects the elbow joint. You would need to be suitable for surgery using either an elbow replacement or having the break fixed with plates and screws.

There are also some time limits involved: your surgery date should be no more than 28 days after you broke your elbow. This helps make sure everyone in the study gets treatment at a similar stage of their injury.

You would not be able to join the study if you have an open wound where the bone broke through the skin, or if your broken elbow is due to cancer that has spread to the bone. Also, if you have other injuries in the same arm that would make it impossible to have one of the two surgeries, or if your doctor thinks another injury or condition would significantly affect your arm's recovery, you wouldn't be able to participate. Finally, if you've already taken part in this specific study before, you can't join again.

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 60 years old or over?
Do you have a broken elbow that affects the joint?
Are you suitable for either elbow replacement or fixing with plates/screws?
Was your elbow injury less than 28 days ago?
Is your broken elbow not an 'open' fracture (bone not poking through skin)?
Do you have any other serious condition in the same arm that would make these surgeries difficult?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly put into one of two groups, like flipping a coin. One group will have an elbow replacement (where part or all of your elbow joint is replaced with an artificial one), and the other group will have internal fixation (where the broken bones are put back together and held with plates and screws). You won't get to choose which surgery you have, but you will receive one of these two standard operations.

Your surgery will be performed by a surgeon who is skilled and experienced in the type of operation you receive. You will also get the same follow-up appointments and physiotherapy that any patient having elbow surgery would receive at your hospital. Taking part in the study doesn't change the care you receive from the NHS.

You will be asked to fill out several questionnaires about your elbow's function and your daily activities. You'll complete one before your surgery, then again at 6 weeks, 4 months, and 12 months after your surgery. There will also be a longer-term check-up and questionnaire at 49 months (just over 4 years) after your surgery. You can fill out these questionnaires during your regular clinic visits or have them sent to you by text, email, or post, whichever you prefer. The study is expected to run from December 2023 to July 2029.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information collected will be very valuable. It will help doctors understand which treatment works best for this type of elbow break, potentially improving care for many people in the future. There is no increased risk from participating in the study itself. Both surgeries used in the study are standard NHS treatments that have been performed for many years. You will face the same risks associated with any surgery and will receive the same high standard of care as patients who have these operations outside of the trial. You are also free to withdraw from the study at any time without affecting your medical care.

Locations (3)

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

Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
City only
Nottingham, England
Royal Infirmary of Edinburgh at Little France
City only
Lothian, Scotland
Wrightington, Wigan and Leigh NHS Foundation Trust
City only
Wigan, England

Common questions

What is an 'elbow replacement'?

It's a surgery where your surgeon replaces a damaged part of your elbow joint with an artificial one made of metal and plastic.

What is 'internal fixation' or 'repair'?

This surgery involves lining up your broken elbow bones and fixing them in place with metal plates and screws while they heal.

Will I get to choose which surgery I have?

No, if you join the study, you'll be randomly assigned to receive one of the two surgeries, like drawing lots.

How long will I be involved in the study?

You'll fill out questionnaires over a year, with a final check-up around 4 years after your surgery.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR HTA Programme) in the UK.

How to find out more

Priya Sharma

priya.sharma2@nottingham.ac.uk N/A Official trial record

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