RecruitingOBSERVATIONAL

Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

This study is looking at two different surgical methods for a specific type of back problem called isthmic spondylolisthesis. This condition can cause back and leg pain. Surgeons can operate either from the front of the body (anterior approach) or from the back (posterior approach) to help fix it. Right now, doctors aren't sure which method is consistently better, so this study aims to find out. They will be watching how much leg pain patients have one year after surgery, and also looking at things like side effects, future surgeries, and how much the surgery improves a person's life and activity levels over time.

At a glance

Status

Recruiting

Sponsor

University of British Columbia

Enrolment target

489

Start

05 Jan 2023

Estimated completion

15 Feb 2038

Isthmic Spondylolisthesis

What is this study about?

This research study is about a back condition called isthmic spondylolisthesis. This happens when one of your spine bones, called a vertebra, slips forward over the one below it. This slippage can press on nerves, leading to pain in your back and legs. When this pain becomes severe and doesn't get better with other treatments, surgery might be an option.

Currently, there are two main ways surgeons can do this specific type of operation: either by approaching the spine from the front of your body (called an anterior approach) or from the back (called a posterior approach). Both methods involve a procedure called 'interbody fusion,' which aims to permanently join the slipped spinal bones together to stabilise the area. Right now, doctors aren't sure which of these approaches is best for most patients. This study wants to compare these two methods side-by-side to see which one leads to better results for patients.

The main goal is to see which surgery is more effective at reducing leg pain after one year. The study will also look at other important things, like how often patients experience side effects, if they need more surgery in the future, if their spine remains properly aligned, and how much their overall quality of life improves. Researchers will follow patients for a long time – up to ten years – to get a complete picture of the long-term effects of each surgical method.

Key takeaways

Compares two surgical methods for a slipping spine bone problem.
Aims to find out which surgery best reduces leg pain.
Looks at long-term results, including side effects and quality of life.
Follows patients for up to 10 years after surgery.
Open to adults needing surgery for this specific back condition.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have a diagnosis of isthmic spondylolisthesis at only one level of your lower back and need surgery for it. Also, you should be able to speak either English or French to communicate with the study team.

There are some reasons why you wouldn't be able to join. For example, if you've had spine surgery before, this study wouldn't be right for you. Also, if you have certain other specific problems with the bones directly above or below the area needing surgery, you wouldn't be eligible. The study is open to both men and women.

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?
Do you need surgery for a slipping spine bone (isthmic spondylolisthesis) in your lower back?
Do you speak English or French?
Have you *not* had spine surgery before?
Is your slipping spine bone problem only at one level of your spine?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to have one of the two types of fusion surgery for your back problem – either the anterior (front) approach or the posterior (back) approach. The doctors will follow your health and pain levels closely. You'll have check-ups and assessments at 1 year, 2 years, 5 years, and 10 years after your surgery. These appointments will involve answering questions about your leg pain and how you're feeling overall, as well as checking your spinal alignment with scans. The total duration of follow-up for the study will be up to 10 years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving one of the standard surgical treatments for your condition, with close monitoring of your progress and potential improvements in leg pain and quality of life. However, like any surgery, both procedures carry potential risks, such as infection, bleeding, nerve damage, or the possibility that the fusion doesn't heal properly. You will be fully informed of these risks before you agree to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'isthmic spondylolisthesis'?

It's a back problem where one of your lower spine bones slips slightly forward over the bone below it, which can cause pain.

What does 'interbody fusion surgery' mean?

It's an operation to join two spinal bones together permanently, making that part of the spine stable and reducing pain.

What's the difference between 'anterior' and 'posterior' surgery?

Anterior means the surgeon operates from the front of your body, while posterior means they operate from the back.

Why don't doctors already know which surgery is best?

Both methods are used, but there hasn't been enough research to clearly show if one is consistently better than the other for all patients.

How long will I be involved in this study?

The study will follow your progress with check-ups for up to 10 years after your surgery.

How to find out more

Charlotte Dandurand

charlotte.dandurand@vch.ca (604) 875-5859 Official trial record

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