Active not recruitingNAINTERVENTIONAL

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

This study is called the 'STABLE Definitive Trial' and is looking for adults aged 18-50 who have had their shoulder dislocate more than once. When a shoulder dislocates, it can be painful and affect your daily life. This trial compares two common surgical procedures to fix it: the Bankart procedure (often with Remplissage) and the Latarjet procedure. The Bankart operation tightens the soft tissues in your shoulder, while the Latarjet operation involves moving a small piece of bone to make your shoulder more stable. The main goal is to find out which operation leads to better shoulder function and fewer future dislocations over two years, helping doctors choose the best treatment for patients with recurring shoulder problems.

At a glance

Status

Active not recruiting

Phase

Sponsor

McMaster University

Enrolment target

114

Start

17 Oct 2023

Estimated completion

01 Jun 2027

Shoulder Dislocation Sport Injuries Anterior Dislocation

What is this study about?

Your shoulder is a very flexible joint, which allows it a wide range of movement. However, because it's so flexible, it can sometimes become unstable and dislocate, especially if you play sports or have an injury. This can be painful and often leads to the shoulder dislocating again and again. Over time, repeated dislocations can even increase the risk of developing arthritis in the shoulder.

When your shoulder keeps dislocating, surgery can help make it more stable, improve your movement, and potentially reduce the chance of arthritis. There are two main operations doctors often use for this: the Bankart procedure (sometimes with Remplissage) and the Latarjet procedure. The Bankart operation focuses on tightening the soft tissues around the front of your shoulder. The Latarjet operation, on the other hand, involves transferring a small piece of bone to the front of your shoulder to provide more support.

Doctors want to understand which of these two operations works best for people with ongoing shoulder instability. This study will follow participants for 24 months (two years) to see how well their shoulder recovers, how much movement they regain, and if they experience fewer dislocations. By comparing these two treatments, the study aims to give doctors clearer guidance on the most effective way to help patients achieve long-term shoulder stability and comfort.

Key takeaways

Compares two common shoulder operations: Bankart (+Remplissage) and Latarjet.
Aims to find which surgery works best for recurring shoulder dislocations.
Looks at shoulder recovery and how often dislocations happen over two years.
Open to adults aged 18-50 with frequent shoulder dislocations.
Participation involves either surgery and follow-up for 24 months.
Helps doctors improve treatment for future patients with shoulder instability.

Who may be eligible?

To join this study, you need to be an adult between 18 and 50 years old. You must have experienced your shoulder dislocating at least twice due to an injury, and doctors need to confirm this with X-rays or by seeing your shoulder put back into place. Also, scans of your shoulder must show a specific amount of bone loss, but not too much.

There are also some reasons why you might not be able to join. For example, if you have other injuries in the same shoulder, like a torn rotator cuff, or if you've had shoulder surgery before, you won't be eligible. Conditions like epilepsy, certain connective tissue disorders (like Ehlers-Danlos syndrome), or if you're pregnant, would also mean you can't take part. They also can't include you if you're involved in a lawsuit over your injury or if your injury is part of a workplace insurance claim.

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?
Has your shoulder dislocated at least twice due to an injury?
Do you have no other major injuries in the same shoulder (like a torn muscle)?
Have you never had surgery on this shoulder before?
Are you not pregnant?
Do you not have certain health conditions like epilepsy or specific connective tissue disorders?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to receive one of the two surgery types: either the Bankart procedure (possibly with Remplissage) or the Latarjet procedure. You won't get to choose which surgery you receive. After your surgery, the study will involve regular follow-up visits to check your shoulder's recovery and function. These visits will likely include physical examinations and questions about your pain and how well you can use your arm. The total duration of your participation in the study will be two years (24 months) after your surgery.

Potential risks and benefits

Participating in this study might offer you the benefit of getting either of two established surgeries for shoulder instability, carefully monitored by medical professionals. However, as with any surgery, there are potential risks, including complications from the procedure itself, infection, or the possibility that your shoulder might dislocate again. 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 'dislocated shoulder'?

A dislocated shoulder is when the ball of your arm bone pops out of the socket of your shoulder blade. It's usually painful and makes it hard to move your arm.

What's the difference between the two operations?

The Bankart operation tightens the soft tissues and ligaments to hold the shoulder in place, while the Latarjet operation uses a small bone graft to create a bigger barrier to stop dislocations.

Will I get to choose which surgery I have?

No, if you join the study, you'll be randomly assigned to one of the two surgery groups, like drawing lots. This helps ensure fair comparison.

How long will I be involved in the study?

Your involvement in the study will last for 24 months (two years) after your surgery, with follow-up appointments during that time.

What if my shoulder dislocates again after the surgery?

The goal of both surgeries is to prevent future dislocations. If it happens, your medical team will assess and discuss further steps with you, as with standard care.