RecruitingNAINTERVENTIONAL

TSA vs RSA in Glenohumeral Osteoarthritis

This study is looking into which of two common shoulder replacement operations, called Total Shoulder Arthroplasty (TSA) and Reverse Shoulder Arthroplasty (RSA), is better for older people with shoulder arthritis. Shoulder arthritis happens when the smooth cartilage in your shoulder joint wears away, causing pain and difficulty moving. Both TSA and RSA are operations to replace the worn-out parts of the shoulder joint with new, artificial ones. The researchers want to compare these two procedures in people aged 65 and over to see which one leads to better quality of life and improved function in the long term. This is important because understanding the best treatment can help doctors decide which surgery is most suitable for you.

At a glance

Status

Recruiting

Phase

Sponsor

Ottawa Hospital Research Institute

Enrolment target

108

Start

09 Mar 2020

Estimated completion

31 Dec 2032

Osteoarthritis of the Shoulder

What is this study about?

This study is looking at people who have shoulder arthritis, which is a condition where the smooth surfaces at the ends of your bones in the shoulder joint wear down over time. This wear and tear can make your shoulder painful and stiff, making everyday activities difficult. Two common operations to help with this are Total Shoulder Arthroplasty (TSA) and Reverse Shoulder Arthroplasty (RSA), where parts of the worn joint are replaced with new, artificial ones.

In a TSA operation, the surgeon replaces the 'ball' and 'socket' parts of the shoulder joint, trying to keep the natural shape of your shoulder. This surgery often works very well, but sometimes there can be problems, especially if the bone of the socket (called the glenoid) has worn away unevenly. An RSA operation is a bit different – it's like reversing the ball and socket, changing their positions. This type of surgery is often used for older patients, especially if there's damage to the muscles around the shoulder (the rotator cuff) or more severe arthritis. While RSA can greatly improve movement and reduce pain, doctors are still learning about its long-term effects.

Currently, there haven't been many studies directly comparing these two operations in older people. This research aims to fill that gap. By carefully comparing TSA and RSA, the study hopes to provide doctors with clearer information about which type of surgery might offer the best results for people aged 65 and over with shoulder arthritis. The main goal is to find out which operation leads to a better quality of life and helps people use their arm more effectively.

Key takeaways

This study compares two shoulder replacement surgeries (TSA and RSA) for people over 65 with shoulder arthritis.
It aims to find out which surgery leads to a better quality of life and improved arm function.
Participation involves either a TSA or RSA surgery, randomly assigned.
You'll have follow-up appointments for up to 5 years to assess your recovery.
The study helps doctors understand the best treatment options for older patients with shoulder arthritis.

Who may be eligible?

To be considered for this study, you would typically be 65 years old or older and have long-lasting shoulder arthritis that hasn't improved with other treatments like pain medication, physiotherapy, or changing your activities. Doctors would also need to see clear signs of advanced arthritis in your shoulder on scans. Your shoulder socket should also be in a certain position, which doctors call having 'equal to or less than 15 degrees of glenoid retroversion'.

There are also reasons why you might not be able to join. For example, if you have an active infection, a different kind of shoulder problem called 'rotator cuff arthropathy', or severe muscle weakness around your shoulder. You also wouldn't be able to take part if you have other serious health problems that might make surgery risky, are pregnant, or have a mental health condition that makes it hard to understand the study. Lastly, if you've had previous surgery on the same shoulder or cannot commit to the follow-up appointments, you would not be eligible.

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 65 years old or older?
Do you have shoulder arthritis that hasn't improved with other treatments?
Have you NOT had previous surgery on the affected shoulder?
Do you NOT have an active infection or other serious health issues?
Are you willing and able to attend follow-up appointments for up to 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either a Total Shoulder Arthroplasty (TSA) or a Reverse Shoulder Arthroplasty (RSA) operation. Which surgery you get would be decided randomly, like flipping a coin. After your surgery, the research team would check in with you several times over a period of up to 5 years. During these visits, you would likely answer questions about your shoulder pain, how well you can use your arm, and your general quality of life. These check-ups will happen at specific times, such as 24 months and 5 years after your operation. The total duration of your involvement in the study would be up to 5 years.

Potential risks and benefits

Taking part in this study could potentially offer you the benefit of receiving one of the two standard shoulder replacement surgeries from experienced surgeons, and contributing valuable information that could help future patients. However, as with any surgery, there are potential risks, including those commonly associated with shoulder operations like infection, pain, or problems with the new joint. The specific risks will be discussed in detail by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

University of Alberta
Verified postcode
Edmonton, Canada· Not yet recruiting
Pan Am Clinic Foundation
Verified postcode
Winnipeg, Canada· Not yet recruiting
Kingston General Hospital (Site-Watkins 3)
Verified postcode
Kingston, Canada· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is shoulder arthritis?

Shoulder arthritis happens when the smooth lining (cartilage) in your shoulder joint wears away, causing pain and stiffness.

What is the difference between TSA and RSA?

Both are shoulder replacement surgeries. TSA replaces the 'ball' and 'socket' in their natural positions. RSA reverses their positions, which is often used for certain types of shoulder problems or in older patients.

Will I get to choose which surgery I have?

No, in this study, which surgery you receive (TSA or RSA) will be decided randomly, like drawing lots.

How long will I be involved in the study?

You would be involved in the study for up to 5 years, with follow-up appointments to check on your recovery.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, without it affecting your care or your relationship with your doctors.

How to find out more

Peter Lapner Lapner, MD

plapner@toh.ca 613-737-8899 Official trial record

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