RecruitingOBSERVATIONAL

Exactech Shoulder Post Market Clinical Follow-up Study

This research study, called the Exactech Shoulder Post Market Clinical Follow-up Study, wants to understand how Exactech shoulder replacements perform over many years. It focuses on the safety and long-term results for people with various shoulder problems, such as different types of arthritis, rotator cuff tears, and fractures. If you have (or have had) an Exactech shoulder replacement, you might be asked to participate. The study will track patients for at least 10 years, gathering information on how their new shoulder works and any changes seen on X-rays. This helps doctors and patients make informed decisions about shoulder surgery in the future.

At a glance

Status

Recruiting

Sponsor

Exactech

Enrolment target

20,000

Start

19 Jul 2007

Estimated completion

31 Dec 2031

Osteo Arthritis Shoulders Osteonecrosis Rotator Cuff Tears Rotator Cuff Tear Arthropathy Ankylosing Spondylitis Post-traumatic Osteoarthritis Rheumatoid Arthritis Fracture Infections

What is this study about?

This study is called the Exactech Shoulder Post Market Clinical Follow-up Study. It's designed to keep a close eye on how well Exactech shoulder replacements work in the real world, after they've been used in patients. The main goal is to collect detailed information about their safety and performance over a long period. "Post Market" simply means that the shoulder replacement is already approved and being used in routine surgeries.

The researchers will be specifically looking at people who have received an Exactech shoulder replacement for various shoulder conditions. These include common issues like arthritis (where the joint lining wears away), osteonecrosis (when bone tissue dies), rotator cuff tears (damage to the muscles and tendons around the shoulder), and fractures. By studying a wide range of patients, they hope to get a comprehensive picture of how the device performs in different situations.

This is a long-term study, meaning participants will be followed for a minimum of 10 years. This extended follow-up is really important because it allows researchers to see how the shoulder replacement holds up over time, rather than just in the short term. They will collect information on how patients are doing clinically (how much pain they have, how well they can move their arm) and radiographically (what X-rays show about the implant and surrounding bone). This information is crucial for improving future shoulder replacement treatments.

Key takeaways

This study aims to understand the long-term performance of Exactech shoulder replacements.
It collects information on safety and effectiveness for various shoulder conditions.
Participants will be followed for a minimum of 10 years.
Data will include clinical assessments and X-rays.
It helps doctors and patients make informed decisions about shoulder surgery.

Who may be eligible?

To be able to take part in this study, you would generally need to have had (or be scheduled for) a shoulder replacement operation. You must also be physically mature and expected to live for at least two years after the surgery. It's important that you're willing to come to all the required appointments before and after your surgery and that you're happy to read and sign a consent form, showing you understand what's involved.

There are also several reasons why you might not be able to participate. For example, if you have an active infection in your bone or elsewhere that could affect the shoulder. You also wouldn't be able to join if your shoulder bone is too weak or malformed to support the new joint, or if you have certain nerve or muscle conditions that would prevent you from controlling your arm properly. The study also excludes people who are pregnant, in prison, or have allergies to the materials used in the implant.

Ultimately, the surgeon will assess if your age, weight, or activity level might make the shoulder replacement fail too quickly. If you are unable or unwilling to follow the instructions given after your surgery, or if you have any other illness that could negatively affect the implant's lifespan, you would not be able to take part.

Quick self-check

Have you had, or are you going to have, an Exactech shoulder replacement?
Are you physically mature (not still growing)?
Are you able and willing to attend follow-up appointments for at least 10 years?
Do you have good general health, and your surgeon expects the implant to last a reasonable time?
Do you not have an active infection in your shoulder area or other conditions preventing safe surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be followed for a long time – at least 10 years. This will involve attending appointments before and after your shoulder surgery. During these visits, the study team will gather information about your shoulder, likely including how much pain you have, how well you can move your arm, and your general quality of life. They will also take X-rays to see how the shoulder replacement is positioned and if there are any changes over time. You won't be given any new medications as part of the study; it focuses on observing the standard care you receive and the performance of your shoulder implant.

Potential risks and benefits

Taking part in a study like this helps improve our understanding of shoulder replacements, which could benefit future patients. The primary benefit for you is contributing to medical knowledge. There are no direct personal medical benefits beyond the standard care you would receive for your surgery. Potential risks are generally linked to the usual surgical procedures you would undergo, as the study involves monitoring existing treatments rather than trying new ones. However, there is the time commitment required for follow-up appointments. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (38)

South County Orthopedic Specialists
Laguna Woods, United States· Recruiting
Stanford Health Care
Redwood City, United States· Recruiting
Alpine Orthopaedic Medical Group
Stockton, United States· Recruiting
Western Orthopaedics
Denver, United States· Recruiting
Orthopaedic and Spine Center of the Rockies
Fort Collins, United States· Recruiting
UF Health Orthopaedics and Sports Medicine Institute
Gainesville, United States· Recruiting
Mayo Clinic
Jacksonville, United States· Recruiting
Palm Beach Orthopaedic Institute
Palm Beach Gardens, United States· Recruiting
Florida Atlantis Orthopedics
Palm Beach Gardens, United States· Recruiting
Orthopaedic Medical Group of Tampa Bay
Tampa, United States· Recruiting
Orthopedic and Sports Medicine
Augusta, United States· Recruiting
OrthoIllinois
Rockford, United States· Recruiting

+26 more sites — see the official record for the full list.

Common questions

What is the study trying to find out?

It's observing how well Exactech shoulder replacements work over a long period, looking at their safety and effectiveness for various shoulder conditions.

How long will I be involved in the study?

You'll be followed for at least 10 years, starting from when you have your shoulder replacement surgery.

Will I have to take any new medicines?

No, this study doesn't involve any new medicines. It's about observing the long-term performance of the shoulder replacement you already have or are getting.

Can I leave the study if I change my mind?

Yes, your participation is completely voluntary. You can withdraw from the study at any time, and it won't affect your medical care.

Who can take part in this study?

Those who have had or are having a shoulder replacement, are physically mature, in generally good health, and willing to attend follow-up appointments.

How to find out more

Rachael Craig

rachael.craig@exac.com 352-377-1140 Official trial record

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