RecruitingNAINTERVENTIONAL

SPECT/CT Bone Scan Quantification Surgery

This study is investigating whether a specific type of bone scan, called a SPECT/CT, done before back surgery, can help predict who will benefit most. The surgery, called lumbar arthrodesis, aims to fuse bones in the lower back to relieve long-term pain. Many people suffer from chronic lower back pain, and surgery is sometimes an option when other treatments haven't worked. Currently, it's hard to tell beforehand who will have a good outcome from this surgery. Researchers hope that by measuring specific signals on the bone scan, they can better identify patients who are likely to experience significant pain relief and improved quality of life after their operation. This could help doctors make more informed decisions with their patients.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

Start

29 Apr 2022

Estimated completion

29 Nov 2025

Pseudoarthrosis of Bone

What is this study about?

This research study is about helping people who have ongoing lower back pain, especially when other treatments haven't worked, and surgery is being considered. The specific surgery in question is called lumbar arthrodesis, which involves joining together (fusing) bones in the lower back to stabilise them and reduce pain. While this surgery can be very helpful for many, it doesn't work for everyone, and currently, doctors don't have a reliable way to predict who will get the most benefit.

The study wants to see if a special type of bone scan, called a SPECT/CT scan, can provide clues. This scan helps doctors see how active the bones are. The researchers believe that by looking at specific measurements from this scan before surgery, they might be able to identify patients who are more likely to experience good results – meaning less pain and a better quality of life – after their back operation. This could be a really important step forward in making sure the right people get the right treatment.

Ultimately, if this study is successful, it could mean that in the future, doctors could use this advanced bone scan to better advise patients contemplating lumbar arthrodesis. It could help avoid unnecessary surgery for those less likely to benefit and ensure that those who are good candidates can proceed with more confidence, leading to improved patient outcomes and reduced long-term pain.

Key takeaways

This study investigates if a special bone scan (SPECT/CT) predicts surgery success for back pain.
It aims to identify patients most likely to benefit from lumbar arthrodesis (back fusion surgery).
Participation involves a pre-surgery scan and follow-up questionnaires about pain and daily life.
The study hopes to improve how doctors choose patients for back surgery.
Your medical treatment and surgery plan will not be changed by taking part.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has been experiencing lower back pain for at least three months. This pain is thought to be caused by issues like degenerative disc disease or spondylolisthesis. You must be considering lumbar arthrodesis surgery for no more than two levels of your spine, performed by one of the specific senior neurosurgeons at Nancy CHRU. You also need to have understood the study information and signed a consent form.

There are certain reasons why you wouldn't be able to join. For example, if your back pain is primarily from nerve damage (neuropathic pain), or if you've had surgery on your lower back before. Other medical conditions that might cause back pain (like certain types of arthritis, infections, or cancer), or if you are pregnant, breastfeeding, or of childbearing age without effective contraception, would also exclude you. You shouldn't have an allergy to the specific material used in the bone scan.

Finally, if you are unable to stay still during scans, or if you are under certain legal or medical restrictions (such as being detained or lacking the ability to make your own decisions), you would not 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 18 years old or older?
Have you had lower back pain for at least three months?
Is your back pain thought to be due to degenerative disc disease or spondylolisthesis?
Are you scheduled for lumbar arthrodesis surgery on no more than two levels of your spine?
Have you *not* had previous lower back surgery?
Are you *not* pregnant or breastfeeding, and using effective contraception if you are a woman of childbearing age?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a special bone scan called a SPECT/CT before your planned lumbar arthrodesis surgery. This scan involves a small amount of a safe, temporary radioactive tracer being injected into your body, which helps the scanner create detailed images of your bones. After your surgery, doctors would continue to monitor your recovery. You will be asked to fill out questionnaires to assess your pain levels and how your back pain affects your daily life. These questionnaires would likely be completed over a period to see how you are improving after the operation. The total duration of your participation would involve the pre-operative scan and follow-up assessments after your surgery.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping future patients. While there isn't a direct personal health benefit from the study's experimental aspects (as the scan is for research, not changing your immediate treatment), your participation will contribute to medical knowledge and potentially lead to better ways of predicting who will respond well to back surgery. The main risk involves the SPECT/CT scan, which uses a small amount of radiation, similar to other medical scans, but this is carefully managed. There's also a tiny chance of an allergic reaction to the injection used for the scan. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Nuclear Medicine Department
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is lumbar arthrodesis surgery?

It's a type of back surgery that involves joining together (fusing) bones in your lower back to help stabilise them and reduce pain.

What is a SPECT/CT bone scan?

It's a special scan that combines two types of imaging to create very detailed pictures of your bones, showing how active they are. A small, safe amount of tracer is injected first.

Will taking part in this study change my surgery?

No, the study won't change your surgery plan. The scan information is for research purposes to help understand who best responds to surgery in the future.

Is the SPECT/CT scan safe?

Yes, it uses a small, controlled amount of radiation, similar to other common medical scans, and is generally considered safe. You will be informed of all potential risks.

Can I leave the study if I change my mind?

Absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Achraf BAHLOUL, MD

a.bahloul@chru-nancy.fr 383153911 Official trial record

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