RecruitingNAINTERVENTIONAL

RCT Evaluating First Time Shoulder Dislocation

If you've dislocated your shoulder for the first time, this study might be for you. Researchers are comparing two ways to help your shoulder: a type of surgery called Bankart and Remplissage, or non-surgical treatments. The main goal is to find out which approach is better at stopping your shoulder from dislocating again and helping it work properly over a two-year period. This first study is a small pilot to check if a larger study is possible. Shoulder dislocations are common, especially in younger people, and can affect daily life and sports. Understanding the best treatment can help many avoid future problems.

At a glance

Status

Recruiting

Phase

Sponsor

McMaster University

Enrolment target

100

Start

12 Jul 2023

Estimated completion

01 Mar 2028

Shoulder Dislocation Sport Injury Anterior Dislocation

What is this study about?

Imagine your shoulder is like a ball and socket, and sometimes the ball can pop out of the socket – that's a dislocation. It's a common injury, especially if you're active or younger. After a first dislocation, there's a risk it might happen again; this is called a 'recurrence'. For some people, particularly younger individuals, this risk can be quite high, affecting activities like sports and daily life. Doctors want to find the very best way to help people who have dislocated their shoulder for the first time.

This study is a first step to compare two approaches: either having an operation or choosing non-surgical care. The operations being looked at are specific and are called 'Bankart' and 'Remplissage' procedures, which aim to fix parts of your shoulder that often get damaged when it dislocates. Non-surgical care might include things like physical therapy and exercises.

By comparing these two options, the researchers hope to learn which one is better at stopping the shoulder from dislocating again in the future and helping it get back to working well. This information can then help doctors make clearer recommendations to patients about the best treatment plans to prevent future problems and improve their shoulder health.

Key takeaways

This study compares surgery vs. non-surgical care for a first-time shoulder dislocation.
It aims to find the best way to stop the shoulder from dislocating again.
The study will follow participants for two years to track their shoulder health.
It's a pilot study, meaning it's a small-scale trial to plan a larger one.
It could help improve future treatments for shoulder dislocations in people aged 14-40.

Who may be eligible?

To join this study, you would generally need to be between 14 and 40 years old. You must have dislocated your shoulder for the very first time within the last three months, and doctors need to have confirmed this through scans or examination.

There are certain reasons why you might not be able to join. For example, if you can't have surgery or general anaesthesia. You also shouldn't have other major injuries to your shoulder, like a broken bone or a torn rotator cuff, or have had shoulder surgery before.

Other reasons you might not be eligible include having epilepsy, being pregnant, or if your shoulder just dislocates easily without any injury. If your dislocation is part of a legal claim, like an accident at work, you also wouldn't 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.

Are you between 14 and 40 years old?
Did your shoulder dislocate for the first time within the last 3 months?
Are you able to have surgery and general anaesthesia?
Do you have any other major shoulder injuries (like a break or rotator cuff tear)?
Have you ever had shoulder surgery before?
Are you pregnant?

Answer every question to see your result.

What does participation involve?

This is a pilot study, which means it's a smaller, early-stage study to see if a bigger one is possible. If you decide to take part, you would either have surgery (Bankart + Remplissage) or follow a non-surgical treatment plan. The researchers would then follow your progress for two years. During this time, they would monitor how often your shoulder dislocates again and how well your shoulder is working through regular check-ups and assessments. The exact number of visits isn't specified in detail, but you can expect regular follow-ups to track your recovery and shoulder health over the two-year period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer monitoring of your shoulder recovery and possibly receive a treatment that could reduce the chance of future dislocations. However, as with any surgery, there are risks like infection or problems with healing. Non-surgical options also have risks, such as the shoulder dislocating again. No matter what, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

St. Joseph's Healthcare Hamilton
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What does 'first-time shoulder dislocation' mean?

It means your shoulder has popped out of its joint for the very first time, not that it's happened before.

What is 'Bankart + Remplissage Procedure' surgery?

These are specific surgical techniques used to fix damaged parts of your shoulder that can lead to it dislocating again.

What does 'non-operative management' involve?

This usually means treatments that don't involve surgery, such as physical therapy, exercises, and careful management of your activities.

How long will I be involved in the study?

The study will follow your progress for two years after your shoulder dislocation.

What if my shoulder dislocates again?

The study will track how often dislocations happen again, as this is one of the main things they want to learn about the treatments.

How to find out more

Danielle Dagher, MSc

ddagher@stjoes.ca 905-522-1155 Official trial record

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