RecruitingNAINTERVENTIONAL

Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis

This research is exploring two different surgical methods for treating a common back problem called degenerative lumbar spondylolisthesis, where a bone in your lower back slips out of place. The two methods are called 'midline' and 'paramedian' approaches. Doctors want to find out if one approach is better than the other in terms of reducing infections after surgery, decreasing the need for further operations, making hospital stays shorter, and ultimately saving money for the healthcare system. This is a small, initial study to gather information for a potentially larger study in the future. Participants will be randomly assigned to receive one of the two surgical approaches, and their recovery and costs will be tracked for a few months.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

100

Start

30 Jan 2018

Estimated completion

31 Dec 2025

Spondylolisthesis, Lumbar Region

What is this study about?

When people need surgery for a slipped bone in their lower back (called degenerative lumbar spondylolisthesis), doctors often join bones together in a procedure called fusion. However, complications like infections and needing another operation can sometimes happen, which can make things more difficult for the patient.

Doctors are interested in finding out if the way they access the spine during this surgery makes a difference. Currently, there are two main approaches: a 'midline' approach and a 'paramedian' approach. Some previous observations suggest the paramedian approach might lead to fewer problems, but more robust research is needed to be sure. This study is a first step to gather crucial information. It's a 'pilot study', which means it's a smaller, initial investigation designed to see if there's enough evidence to support a bigger, more detailed study later on.

The main goals of this study are to see if one surgical approach leads to fewer infections after surgery, reduces the likelihood of needing another operation, shortens the time patients spend in the hospital, and ultimately lowers the overall costs linked to the procedure. If the paramedian approach shows significant improvements in these areas, it could change how these surgeries are done in the future, benefiting both patients and the healthcare system.

Key takeaways

This study compares two existing surgical approaches for slipped back bones.
It aims to find out if one approach leads to fewer infections or re-operations.
Participation involves being randomly assigned to one of two surgery types.
Follow-up appointments typically last for up to 3 months after surgery.
The goal is to improve future care for people with this back condition.

Who may be eligible?

To be considered for this study, you would typically have a specific type of lower back problem called degenerative spondylolisthesis, where a bone in your lower back has slipped out of place. You would likely experience pain in your back, bottom, and legs, especially when you walk or stand, and feel better when you lie down, sit, or bend forward. Importantly, your leg pain should be more noticeable than your back pain when you're walking or standing.

Your symptoms should have been ongoing for at least six months, and other treatments you've tried haven't helped. You also need to be able to understand English well enough to give your consent and fill out any questionnaires by yourself or with a translator if needed.

However, there are some reasons why you might not be able to join. For instance, if you've had a broken bone due to weak bones (osteoporosis) or if you're taking steroid medication for a long time. You also wouldn't be eligible if you've had surgery on your lower spine before (except for a very small disc removal procedure). Finally, if you have certain other conditions that affect your physical movement, like nerve problems (e.g., peripheral neuropathy), muscle diseases (e.g., multiple sclerosis), or serious long-term illnesses like inflammatory arthritis, you might not be able to participate.

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.

Do you have ongoing back and leg pain from a slipped lower back bone?
Has your pain lasted over 6 months despite other treatments?
Is your leg pain usually worse than your back pain when standing or walking?
Have you NOT had previous lower back surgery (other than a small disc removal)?
Do you NOT have conditions like severe osteoporosis, nerve diseases, or muscular disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be checked to make sure you meet all the requirements. If you're eligible, you'll fill out some questionnaires about your health and how you're feeling. Then, using a computer, you'll be randomly assigned to one of two surgery groups: either the 'midline' or the 'paramedian' surgical approach for your back problem. This means neither you nor your doctor will choose which approach you receive.

After your surgery, your surgeon will complete forms about the operation and your recovery in the hospital. You will then have follow-up appointments at approximately 6 weeks and 3 months after your surgery. During these appointments, you'll be asked to complete the same health questionnaires again, along with a diary to track costs and another questionnaire about your pain. The total duration of your active participation, including follow-up, would be about 3 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to valuable knowledge that could improve future surgical treatments for back problems, potentially leading to safer and more effective procedures for others. There's no guarantee that you will personally benefit directly from participating, as this is a research study to investigate two existing surgical methods. The risks involved are generally those associated with any spinal fusion surgery, such as infection, bleeding, nerve damage, or persistent pain, which your surgeon will discuss with you in detail. There are no additional experimental risks beyond those of standard surgery. Remember, your participation is completely voluntary; you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

QEII Health Sciences Centre - Halifax Infirmary site
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is 'degenerative lumbar spondylolisthesis'?

It's a condition where a bone in your lower back (lumbar spine) slips forward over the bone below it, often due to wear and tear. This can cause back and leg pain.

What's the difference between 'midline' and 'paramedian' surgery?

These are two different ways for surgeons to access your spine during an operation. This study is comparing them to see if one is better.

Will I get to choose which surgery I have?

No, if you join the study, a computer will randomly decide which surgical approach you receive. This helps make the study fair.

How long will I be followed up after surgery?

You will have follow-up appointments at about 6 weeks and 3 months after your operation to check on your recovery and complete questionnaires.

Is this a new type of treatment?

No, this study is comparing two standard surgical approaches that are already used. It's not testing a new or experimental treatment.

How to find out more

Andrew Glennie, MD

andrew.glennie@nshealth.ca 902-473-3707 Official trial record

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