RecruitingOBSERVATIONAL

Total Shoulder Arthroplasty Multi-Center Registry

This study is a large collection of information from many different hospitals about people who are having shoulder replacement surgery. It's designed to see how well patients do after two main types of shoulder replacement: 'anatomic' and 'reverse' total shoulder arthroplasty. By gathering details on at least 1000 patients (500 for each type), the study aims to understand the real-world experiences and results of these operations. The goal is to help doctors learn more about these surgeries, how effective they are, and ultimately improve care for people with shoulder problems. Patients will be asked to join after they've already decided to have the surgery, and their treatment will be just like anyone else's.

At a glance

Status

Recruiting

Sponsor

Arthrex, Inc.

Enrolment target

2,500

Start

28 Jul 2015

Estimated completion

01 Nov 2035

Shoulder Arthroplasty

What is this study about?

Imagine you're having shoulder replacement surgery, perhaps because of pain, stiffness, or an injury. This study is like a large, organised notebook where doctors and researchers are writing down how patients like you get on after their operation. It's called a 'registry' because it's a long-term collection of information from many different hospitals. The main goal is to understand how well two common types of shoulder replacement surgery – called 'anatomic' and 'reverse' – work in real life.

For an 'anatomic' replacement, the new parts are placed in the same way as your natural shoulder joint. A 'reverse' replacement, however, swaps the ball and socket parts around, which can be better for people with certain types of severe shoulder damage or tendon problems. By carefully collecting details from hundreds of patients who have these surgeries, researchers hope to get a clearer picture of their success rates, how long they last, and what helps people recover best.

This study is important because it helps doctors and surgeons learn and improve. By looking at a large number of patients, they can identify patterns and understand what makes a difference to people's recovery and long-term comfort. This knowledge can then be used to help future patients make informed decisions and receive even better care for their shoulder problems.

Key takeaways

This study helps doctors learn about shoulder replacement surgery.
It collects information on two main types: 'anatomic' and 'reverse' replacements.
Your treatment will be exactly the same whether you join or not.
You'll share information about your recovery through questionnaires and follow-up visits.
The study aims to improve shoulder care for future patients.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you would need to be an adult, between 18 and 100 years old. You must have already decided with your doctor to have a primary (first time) or revision (redo) shoulder replacement using a specific type of implant made by Arthrex.

You also need to be willing and able to take part fully. This means you should be able to understand what's involved, fill out questionnaires about how you're feeling, attend follow-up appointments, and follow the exercises prescribed by your physiotherapist after surgery.

There are also a few reasons why you might not be able to join. For example, if you have other commitments or health conditions that would make it difficult for you to complete all parts of the study, you might not be eligible. Your surgeon will talk to you about these details to see if this study is right for you.

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 100 years old?
Have you decided to have a shoulder replacement surgery?
Is your planned surgery using Arthrex brand shoulder parts?
Are you willing to fill out questionnaires about your shoulder?
Are you able to attend your follow-up appointments?
Are you able to follow your post-surgery physiotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your treatment will be exactly the same as if you weren't in the study. You'll still have your planned shoulder replacement surgery, and your surgeon will follow all their usual procedures.

What's different is that some extra information will be collected about your recovery. This will involve filling out questionnaires about your shoulder pain and function at certain times after your operation. You'll also attend regular follow-up appointments, just like any other patient, but the study will record details from these visits. The study aims to follow patients for several years after their surgery to see how they do long-term. You won't be given any special medication or extra treatments just for the study; it's all about observing your standard care.

Potential risks and benefits

Taking part in this study carries no additional physical risks beyond those of the surgery itself, as you will receive the same standard treatment as patients not in the study. There are no direct medical benefits for you, but the information collected will help improve understanding of shoulder replacements for future patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your medical care.

Locations (27)

University of Arizona/Banner Health
Verified postcode
Phoenix, United States· Recruiting
Banner Medical Group
Verified postcode
Phoenix, United States· Recruiting
Orthopedic Surgery (Mayo Scottsdale)
Verified postcode
Phoenix, United States· Recruiting
HCA Research Institute LLC.
Verified postcode
Denver, United States· Recruiting
University of Connecticut Health Center
Verified postcode
Farmington, United States· Terminated
University of Florida
Verified postcode
Gainesville, United States· Recruiting
Andrews Research & Education Foundation
Verified postcode
Gulf Breeze, United States· Recruiting
Advent Health Orlando
Verified postcode
Orlando, United States· Recruiting
NorthShore University Health System
Verified postcode
Evanston, United States· Withdrawn
The Trustees of Indiana University
Verified postcode
Indianapolis, United States· Recruiting
The University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
—
Verified postcode
Grand Rapids, United States· Terminated

Common questions

What is an 'anatomic' vs. 'reverse' shoulder replacement?

An 'anatomic' replacement mimics your natural shoulder joint. A 'reverse' replacement swaps the ball and socket positions, often used for specific shoulder problems or severe tendon damage.

Do I get different treatment if I join the study?

No, your medical care, surgery, and recovery plan will be exactly the same as for any other patient having this operation.

What do I need to do if I join?

You'll be asked to fill out some questionnaires about your shoulder and attend your normal follow-up appointments so the study can collect information on your progress.

How long will I be in the study?

The study collects information over several years to see how patients recover and how well their shoulder replacement works over the long term.

Can I change my mind about taking part?

Yes, you can decide to stop participating at any time without giving a reason, and it won't affect your medical care in any way.

How to find out more

Kelly Ganz, BA, CCRC

kelly.ganz@arthrex.com 1 (800) 933-7001 Official trial record

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