Active not recruitingNAINTERVENTIONAL

Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation

This study is a pilot, meaning it's a small first step to see if a bigger study is possible. It focuses on people aged 18-50 who have dislocated their shoulder more than once. Researchers want to compare two common surgeries to fix repeated shoulder dislocations: the Latarjet procedure and the Bankart + Remplissage procedure. The Latarjet surgery involves moving a small piece of bone to help stabilise the shoulder. The Bankart + Remplissage surgery tightens the soft tissues around the joint. The main goal is to find out which surgery is better at preventing future dislocations and improving shoulder function over 24 months, while also checking how practical it is to run a larger, full-scale trial later on.

At a glance

Status

Active not recruiting

Phase

Sponsor

Moin Khan

Enrolment target

Start

01 Jul 2019

Estimated completion

01 Dec 2027

Shoulder Dislocation Sport Injuries Shoulder Anterior Dislocation

What is this study about?

Our shoulders are amazing joints, allowing us to move our arms in many directions. However, because they're so flexible, they can sometimes become unstable and dislocate, especially after an injury. A dislocated shoulder means the ball of the arm bone has popped out of its socket. For some people, this happens repeatedly, causing pain and making everyday activities difficult.

This study aims to compare two different surgical procedures designed to stop your shoulder from dislocating again. One is called the Latarjet procedure, and it involves taking a small piece of bone from one part of your shoulder and moving it to another to create a stronger barrier against dislocation. The other procedure is called Bankart + Remplissage. This surgery focuses on tightening the damaged soft tissues (like ligaments) that normally help hold your shoulder in place.

The main idea behind this pilot study is to see if it's possible to run a larger, more comprehensive study in the future. Researchers want to find out which of these two surgeries is more effective at preventing further dislocations and improving how well your shoulder works over two years. By understanding this, doctors can make better choices about the best treatment for patients with recurring shoulder dislocations.

Key takeaways

Compares two common surgeries for repeated shoulder dislocations.
Aims to see which surgery best prevents future dislocations and improves function.
Specifically for people aged 18-50 with recurring dislocations after injury.
It's a small 'pilot study' to prepare for a larger research project.
Follows participants for two years after surgery to check results.

Who may be eligible?

This study is looking for men and women between 18 and 50 years old. To be considered, you must have experienced at least two confirmed shoulder dislocations after an injury. Your medical scans (like a CT scan) should also show a specific amount of minor bone loss in your shoulder joint – not too much and not too little.

There are several reasons why you might not be able to join. For example, if you have other shoulder injuries like a torn rotator cuff, or if you've had shoulder surgery before, you wouldn't be eligible. People with certain medical conditions, such as epilepsy or specific connective tissue disorders (like Ehlers-Danlos syndrome or Marfan syndrome), also can't take part.

Additionally, if you are pregnant, have a history of problems keeping appointments, or are involved in legal or insurance claims related to your shoulder injury, this study wouldn't be suitable for you. The researchers want to make sure the study focuses on a very specific group of patients to get clear results.

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 18 and 50 years old?
Have you dislocated your shoulder at least twice after an injury?
Do you have a specific amount of minor bone loss in your shoulder joint?
Have you had any previous shoulder surgery?
Do you have certain conditions like epilepsy or a connective tissue disorder?
Are you currently pregnant or involved in legal claims about your injury?

Answer every question to see your result.

What does participation involve?

As this is a pilot study, specific details about participation aren't fully outlined, but typically, taking part in a study like this would involve several steps. You would first have an assessment to confirm you meet all the eligibility criteria. If suitable, you would then undergo one of the two surgical procedures being compared. Following surgery, you would likely have regular follow-up appointments over a 24-month period. These visits would involve check-ups on your shoulder's recovery, assessments of how well your shoulder is working, and discussions about any further dislocations or issues you might experience. The total duration of your participation would be approximately two years.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving one of two established surgical procedures to treat your recurring shoulder dislocations, potentially reducing future episodes and improving your shoulder function. However, as with any surgery, there are potential risks, including complications from the procedure itself, anaesthesia, and the recovery process. The specific risks for each surgical technique would be fully explained before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is a 'pilot study'?

A pilot study is a small, initial study done before a larger main study. It helps researchers test if the bigger study is possible and practical to carry out.

What does 'shoulder instability' mean?

Shoulder instability means your shoulder joint is loose and prone to dislocating (popping out of its socket) easily, often repeatedly.

What's the main difference between the two surgeries?

The Latarjet procedure uses a small piece of bone to stabilize the shoulder, while the Bankart + Remplissage procedure focuses on tightening the soft tissues around the joint.

How long will the study follow me?

If you take part, you will be followed and assessed for 24 months, which is two years after your surgery.

Will I know which surgery I'm getting?

Many clinical trials 'randomise' participants, meaning you'd be assigned to one of the two surgery groups by chance, like flipping a coin. You might not know which one you're getting until after you've agreed to be in the study.