RecruitingNAINTERVENTIONAL

Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

If you're over 65 and have severe shoulder arthritis that hasn't improved with other treatments, this study might be for you. We're looking at two types of shoulder replacement surgery: Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA). Doctors aren't sure which is best for older patients, so this study aims to compare them. Participants will be randomly chosen to receive either TSA or RTSA. Over 12 months, we'll check how well each surgery helps with pain and movement, how it affects your quality of life, and if there are any complications. This information will help doctors recommend the best treatment in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

30 May 2022

Estimated completion

30 May 2026

Shoulder Osteoarthritis

What is this study about?

If you have advanced arthritis in your shoulder, you know how much it can affect your daily life. It's a common problem, especially as we get older. When treatments like physiotherapy or medicines don't help anymore, doctors might suggest a shoulder replacement operation. This study is for people aged 65 and over who are considering this type of surgery.

There are two main types of shoulder replacement operations: a Total Shoulder Arthroplasty (TSA) and a Reverse Total Shoulder Arthroplasty (RTSA). Both aim to relieve pain and improve movement. However, doctors are currently unsure which of these operations is better for people aged 65 and above. This study is designed to help answer that question.

We want to compare these two operations to see which one leads to better results for patients. This includes looking at how well your shoulder works, how much your pain improves, and your overall quality of life in the first 12 months after surgery. By taking part, you'll be helping doctors understand how to give the best care to older patients with shoulder arthritis in the future.

Key takeaways

This study compares two types of shoulder replacement surgery (TSA and RTSA) for severe arthritis.
It's for people aged 65 and over whose shoulder pain isn't helped by other treatments.
Participants will be randomly assigned to receive one of the two surgeries.
The study will track your recovery, pain, and quality of life for 12 months.
The goal is to find out which surgery works best for older patients.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for people aged 65 or older who have severe shoulder arthritis. You would be considered if your shoulder pain and stiffness haven't gotten better with standard treatments like pain medicines, anti-inflammatory drugs, or physiotherapy for at least six months. Imaging scans (like X-rays or MRI) will also need to show significant damage to the shoulder joint.

You wouldn't be able to join if you have certain other health conditions, such as an active infection, severe muscle weakness in your arm, or other serious illnesses that would make surgery too risky. Also, if you've had previous surgery on the affected shoulder or if you can't understand the study information, you wouldn't be able to take part.

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 severe shoulder arthritis that hasn't improved with other treatments?
Have you tried treatments like pain medicines, anti-inflammatory drugs, or physiotherapy for at least 6 months?
Have you never had surgery on the affected shoulder before?
Do you feel well enough to undergo surgery and attend follow-up appointments for a year?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either a Total Shoulder Arthroplasty (TSA) or a Reverse Total Shoulder Arthroplasty (RTSA). This is like flipping a coin, so neither you nor your doctor can choose which surgery you get. After your surgery, the research team will follow up with you regularly for 12 months. This will involve appointments where they will check your shoulder movement, ask about your pain and how you're feeling generally, and collect information about your daily activities. You'll likely fill out questionnaires at these visits. All of this helps us understand the effects of the surgery. The total duration of your active participation in the study will be 12 months.

Potential risks and benefits

Taking part in this study may offer some benefits, such as contributing valuable information that could improve future care for others with shoulder arthritis. You will also receive one of two common, established shoulder replacement surgeries aimed at reducing pain and improving shoulder function. All surgeries carry risks, such as infection, bleeding, or problems with anaesthesia, and your surgeon will discuss these with you. There's also a chance that the surgery might not fully relieve your symptoms. Remember, you can leave the study at any time without giving a reason, and this won't affect your future medical care.

Locations (8)

Royal Alexandra Hospital (Orthopaedic Surgical Centre)
Verified postcode
Edmonton, Canada· Recruiting
Glen Sather Sports Medicine Clinic (University of Alberta)
Verified postcode
Edmonton, Canada· Recruiting
Kaye Edmonton Clinic
Verified postcode
Edmonton, Canada· Recruiting
Collaborative Orthopaedic Research (CORe), Clinical Sciences Building
Verified postcode
Edmonton, Canada· Recruiting
University of Alberta Hospital
Verified postcode
Edmonton, Canada· Recruiting
Grey Nuns Community Hospital
Verified postcode
Edmonton, Canada· Recruiting
Sturgeon Community Hospital
Verified postcode
St. Albert, Canada· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is shoulder arthritis?

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

What's the difference between TSA and RTSA?

Both are shoulder replacements, but they change the shoulder's ball-and-socket positions differently. We are studying which is better for older people.

Will I get to choose which surgery I have?

No, if you join, you'll be randomly chosen to receive one of the two surgeries, like drawing lots or flipping a coin.

How long will I be involved in the study?

You'll be followed by the research team for 12 months after your surgery to see how you're recovering and feeling.

What if I change my mind about participating?

You can decide to withdraw from the study at any point, and your decision won't affect your medical care.

How to find out more

Ailar Ramadi, PhD

ailar.ramadi@albertahealthservices.ca 780-492-2398 Official trial record

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