RecruitingNAINTERVENTIONAL

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

This research is investigating whether a specific surgery, called duroplasty, can help people with severe spinal cord injuries in their neck. Spinal cord injuries are very serious and can cause permanent problems like paralysis. Standard surgery helps, but this study wants to know if adding duroplasty makes a bigger difference. Duroplasty involves gently opening the tough covering around the spinal cord and adding a patch. Doctors believe this might reduce pressure on the injured cord. We're looking for adults aged 16 and over, with certain neck injuries, who are having surgery within 72 hours of their injury. Participants will be randomly assigned to either standard surgery or standard surgery plus duroplasty to see which treatment leads to better recovery, especially for things like hand movement and walking.

At a glance

Status

Recruiting

Phase

Sponsor

St George's, University of London

Enrolment target

222

Start

08 Oct 2021

Estimated completion

30 Jun 2028

Spinal Cord Injuries

What is this study about?

Spinal cord injuries are incredibly serious and can change a person's life drastically, often leading to lasting problems like not being able to move parts of their body, loss of sensation, and difficulty controlling their bladder and bowels. Currently, there isn't a proven treatment that significantly improves recovery after such an injury. This is why researchers are always looking for new ways to help.

This study is focusing on a specific type of surgery called duroplasty. After a spinal cord injury, the cord can swell, and the tough outer layer around it, called the dura, might press on the injured area. Duroplasty involves carefully opening this dura and stitching in a patch, almost like expanding a tight space. The idea is that this might reduce pressure on the swollen spinal cord, potentially giving it a better chance to heal or recover some function. Early research suggests this procedure might safely and effectively relieve pressure.

The main goal of this research is to find out if adding duroplasty to the standard surgery makes a real difference. Participants will be carefully monitored over a year to see how well they recover. Researchers will assess various aspects, including how well they can use their hands, their ability to walk, and bladder and bowel control, as well as their overall quality of life.

Key takeaways

This study investigates if a surgery called duroplasty improves recovery from severe neck spinal cord injuries.
Spinal cord injuries can cause lasting problems like paralysis, and new treatments are urgently needed.
Duroplasty aims to relieve pressure on the injured spinal cord by expanding its protective covering.
Participants will be randomly assigned to either standard surgery or standard surgery plus duroplasty.
The study assesses movement, sensation, bladder/bowel control, and quality of life over one year.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is designed for adults aged 16 and over who have experienced a severe spinal cord injury in their neck area. To be considered, doctors must believe you need and are suitable for surgery that includes removing part of the bone (called a laminectomy).

It's important that your surgery takes place within 72 hours of your injury for you to be eligible for this study. You (or a family member or legal representative if you can't) also need to be able to understand and agree to take part.

However, you won't be able to participate if your spinal cord injury has already caused a tear in the dura (the tough outer covering), or if you have other serious health problems that might limit your recovery or make surgery too risky. Injuries in the middle or lower back, or other brain or nerve conditions, would also mean you couldn't join this particular study.

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 16 years old or older?
Did you have a severe spinal cord injury in your neck (not your back)?
Is your surgery for this injury happening within 3 days (72 hours) of the injury?
Do you have other serious health problems that might limit your recovery?
Is there a tear in the outer covering of your spinal cord from your injury?
Are you able to agree to take part in the study, or can a family member/representative agree for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, much like flipping a coin. One group will receive the standard surgery for their spinal cord injury. The other group will receive the standard surgery along with the duroplasty procedure. Neither you nor the doctors assessing you will know which group you are in.

Over the next year, you'll have several follow-up appointments. At these appointments, researchers will ask you to complete questionnaires and perform physical examinations to check how well you're recovering. These assessments will look at things like how well you can use your hands, if you can walk, and how well you control your bladder and bowels, as well as considering your general well-being. These checks will usually happen at 3, 6, and 12 months after your surgery.

Some patients might also be asked to take part in a smaller, optional study. This involves placing tiny probes at the injury site during surgery to learn more about how duroplasty works, for example, by checking blood flow. The total duration of your active participation, including assessments, will be one year.

Potential risks and benefits

By taking part in this study, you might benefit from receiving an experimental procedure (duroplasty) that could potentially improve your recovery more than standard care alone. However, like any surgery, duroplasty carries potential risks, including infection, bleeding, or other surgical complications, some of which are already associated with standard spinal surgery. The decision to participate is entirely yours, and you can withdraw from the study at any time without affecting the quality of your medical care.

Locations (33)

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

Universität Klinik für Neurochirurgie
Verified postcode
Innsbruck, Austria· Recruiting
Kepler University Hospital
Verified postcode
Linz, Austria· Recruiting
University Hospital Salzburg
Verified postcode
Salzburg, Austria· Recruiting
St Polten University Hospital
Verified postcode
Sankt Pölten, Austria· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Verified postcode
Wuhan, China· Recruiting
Masaryk Hospital
Verified postcode
Ústí nad Labem, Czechia· Recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Kuopio University Hospital
Verified postcode
Kuopio, Finland· Recruiting
BG Unfallklinik Frankfurt am Main
Verified postcode
Frankfurt, Germany· Recruiting
Hadassah Medical Center
Verified postcode
Jerusalem, Israel· Recruiting
Shaare Zedek Medical Centre
Verified postcode
Jerusalem, Israel· Recruiting

Common questions

What is a spinal cord injury?

It's damage to the bundle of nerves that runs down your back, which can cause problems with movement, feeling, and bodily functions.

What exactly is duroplasty?

It's an operation where doctors gently open the tough wrapper around your spinal cord and add a patch to create more space, hoping to relieve pressure.

Will I definitely get the duroplasty if I join?

No, you'll be randomly assigned to either receive the standard surgery or the standard surgery plus duroplasty, like a coin toss.

How long will I be involved in this study?

You'll be followed up for one year after your surgery, with assessments at key times like 3, 6, and 12 months.

Where will the study take place?

Patients will mainly be recruited from UK Major Trauma Centres, and most follow-up assessments will happen at UK Spinal Injury Centres.

How to find out more

Sophie Reynolds

discus@nds.ox.ac.uk 079 17100953 Official trial record

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