Not yet recruitingNAINTERVENTIONAL

Sacroplasty for Sacral Insufficiency Fractures.

This study is investigating a new procedure called sacroplasty for older adults aged 50 and over who have broken bones in their lower back, often due to weakened bones (osteoporosis). These types of fractures can cause long-lasting pain and make it hard to move around, sometimes leading to other health problems. Traditionally, these breaks are treated with painkillers and physiotherapy. This study wants to find out if sacroplasty, which involves injecting a special bone cement to strengthen the broken bone, can help people recover more quickly, reduce their pain, and improve their overall quality of life and ability to move. Participants will either receive the sacroplasty procedure or standard care, and researchers will compare their progress over several months.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

Start

01 Jan 2027

Estimated completion

01 Dec 2030

Sacral Fracture Osteoporotic Fracture

What is this study about?

Broken bones in the lower back, particularly the sacrum, are quite common in older adults, especially if their bones are weak (a condition called osteoporosis). These breaks, known as sacral insufficiency fractures, might not sound serious, but they can cause a lot of pain, making it difficult to walk or do everyday activities. This can lead to people being less mobile, sometimes needing to stay in bed, which might increase the risk of other problems like chest infections, blood clots, or pressure sores. Recovery can often be very slow, and some people may even lose their independence.

Currently, the usual way to manage these fractures involves pain relief medications, physiotherapy to help with movement, and encouraging people to get back on their feet safely. While these treatments are important, they don't always offer quick relief or a fast return to normal activities. This is where a procedure called sacroplasty comes in. It's a minimally invasive treatment where doctors inject a special bone cement into the broken sacrum to strengthen it.

This study aims to discover if sacroplasty can significantly improve recovery for people with these fractures compared to standard treatment. We want to see if it helps reduce pain more quickly, improves mobility and overall well-being, and ultimately helps older adults regain their independence sooner. The results of this study will help doctors understand the best ways to treat these types of fractures in the future.

Key takeaways

The study compares a procedure called sacroplasty with standard care for lower back fractures.
It aims to see if sacroplasty helps older adults recover faster and with less pain.
Sacroplasty involves injecting special bone cement into the broken bone.
Participants will be randomly assigned to either sacroplasty or standard care.
There will be follow-up checks at 6 weeks and 6 months after starting.
The study will not recommend a treatment, but will gather evidence to help improve care.

Who may be eligible?

To join this study, you need to be 50 years old or older. You must also have a specific type of break in your lower back bone (sacrum) or other back pelvic bones that happened from a minor incident, like a fall from standing height. This break needs to have been confirmed by a scan like a CT or MRI, and you should have had pain for at least 48 hours but for no longer than six weeks.

It's also important that you are considered suitable for the sacroplasty procedure when it's done using a local anaesthetic, meaning the area will be numbed, and you might also be offered some mild calming medicine (sedation) if you wish. You won't be able to join if your break is very severe or unstable and needs major surgery, or if you have an infection or cancer in that area. Also, if you have blood clotting problems that can't be fixed, or if doctors don't think you have at least three months to live, you wouldn't be able to take part.

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 50 years old or older?
Do you have a broken bone in your lower back (sacrum) that happened easily?
Has your pain lasted for more than 2 days but less than 6 weeks?
Are you suitable for a procedure under local anaesthetic (area numbed)?
Do you have good overall health, without a serious infection or cancer in the area?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the sacroplasty procedure, and the other will receive the standard care, which includes pain medication and physiotherapy. The sacroplasty procedure involves injecting bone cement into your broken bone while you are awake but the area is numbed (local anaesthetic), and you can ask for some calming medicine if you'd like. Our doctors will perform this procedure.

Everyone in the study will have follow-up checks. You will need to attend appointments at 6 weeks and 6 months after starting the study. During these visits, we will ask about your pain levels, how well you can move around, if you've needed any other healthcare, and your general quality of life. We'll also check for any side effects. The total duration of your active participation in the study will be 6 months.

Potential risks and benefits

Participating in this study might offer several potential benefits. If you receive sacroplasty, it could lead to faster pain relief and quicker recovery compared to standard treatment, helping you get back to your usual activities sooner. Both options aim to improve your mobility and quality of life. However, like any medical procedure, sacroplasty carries some risks, such as local discomfort, bruising, bleeding, or, very rarely, infection or cement leaking. Standard care also has risks associated with prolonged immobility. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Hull University Teaching Hospitals
Verified postcode
Hull, United Kingdom

Common questions

What is a sacral insufficiency fracture?

It's a broken bone in your lower back (sacrum) that happens easily, usually due to weak bones, not a major accident.

What is sacroplasty?

Sacroplasty is a procedure where a special bone cement is injected into your broken sacral bone to strengthen it and reduce pain.

Will I be put to sleep for sacroplasty?

No, it's done with local anaesthetic to numb the area, and you can also have mild calming medicine if you want to. You'll be awake.

How long will I be in the study?

Your involvement in the study will last for 6 months, with check-ups at 6 weeks and 6 months.

What if I get the standard treatment group?

You will receive the usual care for your fracture, which includes appropriate pain relief and physiotherapy to help you recover.

How to find out more

Research Coordinator

hyp-tr.orthopaedic.research@nhs.net 01482315506 Official trial record

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