RecruitingNAINTERVENTIONAL

Latarjet vs Anatomic Glenoid Reconstruction

Surgical procedures are needed when the shoulder bone is damaged after many dislocations, as this damage can make the shoulder dislocate again and again. This study compares two operations: the Latarjet and the Anatomic Glenoid Reconstruction (AGR). Both aim to rebuild the shoulder socket (glenoid) to make it more stable and less likely to dislocate again. The Latarjet is a well-known operation, but there are some concerns about its complication rates. The AGR is a newer method that seems promising due to fewer problems. Researchers want to compare these two methods closely to find out which one works best for preventing future dislocations and has the fewest side effects, ultimately improving treatment for people with these painful shoulder issues.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

Start

24 Apr 2023

Estimated completion

01 Dec 2026

Shoulder Dislocation Bone Loss Arthroscopy

What is this study about?

If your shoulder keeps dislocating, especially after the humerus (upper arm bone) moves out of the front of the shoulder socket, it can be very painful and limit what you can do. This can happen if the shoulder socket (called the glenoid) gets damaged, making it harder for the shoulder to stay in place. If this is left untreated, the shoulder might keep dislocating over and over again, sometimes 90% of the time or more. The good news is that surgeons can often fix this bone damage to make your shoulder more stable.

This study is looking at two main surgical options for fixing a damaged shoulder socket: the Latarjet procedure and the Anatomic Glenoid Reconstruction (AGR). The Latarjet is a common and trusted operation where a small piece of bone from your shoulder blade is moved and attached to the front of your shoulder socket. This helps create a bigger, more stable socket. The AGR is a newer method that uses a piece of bone, usually from a donor, to rebuild the socket in a way that closely matches its original shape. Both operations aim to stop your shoulder from dislocating again, reduce pain, and improve how well your shoulder works.

The main goal of this research is to directly compare these two operations. Even though both are used, doctors don't yet have enough information to say which one is definitely better for everyone. By comparing them, the study hopes to find out if one leads to fewer complications (unwanted side effects) or is more successful at preventing dislocations in the long term. This information will help doctors choose the best treatment for patients in the future.

Key takeaways

This study compares two important operations for shoulder dislocations caused by bone loss.
It aims to find out which surgery (Latarjet or AGR) is safer and more effective at preventing future dislocations.
Both surgeries rebuild the shoulder socket to make it more stable.
Participation involves being randomly assigned to one of the two surgical procedures.
The study helps improve future treatment options for people with this condition.

Who may be eligible?

To be considered for this study, you would need to be between 16 and 40 years old. You must also have had your shoulder dislocate at least once, and scans need to show that you have a certain amount of bone loss in your shoulder socket, specifically more than 20%.

However, there are reasons why you might not be able to join. For example, if your shoulder tends to dislocate in multiple directions or backwards, or if you have very large tears in your rotator cuff muscles, you wouldn't be suitable. People with a history of substance abuse or those who can't fully understand and agree to take part, or who don't want to be randomly assigned to one treatment group or the other, would also be excluded.

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 16 and 40 years old?
Has your shoulder dislocated at least once?
Have scans (like a CT scan) shown bone loss of more than 20% in your shoulder socket?
Do you not have shoulder instability that causes your shoulder to pop out in different directions (multi-directional instability)?
Have you not had very large tears in the muscles around your shoulder (rotator cuff)?
Are you able to agree to take part and understand the study information fully?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive either the Latarjet operation or the Anatomic Glenoid Reconstruction (AGR) operation. This means you wouldn't get to choose which surgery you have, similar to flipping a coin.

Before and after your surgery, you would have several check-ups. These would involve doctors looking at how well your shoulder is working and taking scans, like X-rays, to see how the bone is healing and if it's stable. You would also be asked to fill out questionnaires about your pain and how your shoulder feels and functions in your daily life. The research team will explain the full schedule of these visits and assessments, which will take place over a period of time after your surgery.

Potential risks and benefits

Participating in this study could offer several potential benefits, such as receiving one of two established surgical procedures to stabilise your shoulder and reduce future dislocations, which may improve your pain and shoulder function. However, like all surgeries, both procedures carry potential risks, including infection, nerve injury, stiffness, or the possibility of the shoulder dislocating again. There's also the chance that the specific procedure you receive as part of the study might not be the most effective for you individually. It's important to remember that joining a clinical study is completely voluntary, and you have the right to withdraw at any time, even after agreeing to participate, without affecting your standard medical care.

Locations (1)

Nova Scotia Health QEII Halifax Infirmary
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is a shoulder dislocation?

It's when the ball (top of your arm bone) pops out of the socket (part of your shoulder blade). It's very painful and makes your arm hard to move.

Why do some people need surgery for shoulder dislocations?

If your shoulder keeps dislocating, it can damage the bone in the socket. Surgery rebuilds this damaged bone to make your shoulder more stable and prevent future dislocations.

What is 'bone loss' in the shoulder?

This means that repeated dislocations have caused parts of the shoulder socket to wear away or break off, making the socket shallower and less able to hold the arm bone in place.

What's the difference between the Latarjet and AGR operations?

Both operations aim to fix the bone loss. Latarjet uses a piece of your own bone from the shoulder blade. AGR uses a piece of donor bone to rebuild the socket more precisely.

Will I know which surgery I'll get if I join this study?

No, you won't. You'll be randomly assigned to one of the two surgery groups, like drawing lots. This helps researchers compare the treatments fairly.

How to find out more

Ivan Wong, MD

research@drivanwong.com 9024737626 Official trial record

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