Upstate is part of national innovative shoulder replacement implant study
SYRACUSE, N.Y.-- Upstate Medical University is enrolling adults in a two-year study to test the safety and effectiveness of a new shoulder replacement system for people with degenerative shoulder joint disease. The trial compares the Arthrex Eclipse Shoulder Prosthesis to a more conventional prosthesis among people receiving total shoulder replacement surgery. Upstate is among 15 sites in the U.S. to test the system.
“Shoulder replacement surgery involves the removal of the damaged part of the shoulder, replacing it with artificial components, called a prosthesis,’ said Kevin J. Setter, M.D., associate professor of orthopedic surgery, who is leading Upstate’s participation in the study. “People with different types of arthritis and other conditions causing pain and disability are candidates for the procedure.”
The shoulder is a ball and socket joint with the top of the upper arm shaped like a ball. Traditional shoulder replacement surgery attaches the new ball joint to a large metal stem inserted into the upper arm. The new “stem-less” procedure under investigation fixes the ball joint at the top of the upper arm with a special screw, without inserting a stem all the way through the upper arm.
Since the Arthrex Eclipse avoids the insertion of a long stem, it is a much less invasive surgery designed to preserve more healthy bone and tissue in the shoulder. This may reduce pain and make the new joint function more naturally. While it remains an investigational device in the United States, the Arthrex Eclipse has been approved for use in Europe and Canada, where thousands of procedures have been completed.
To qualify for the study:
Patients enrolled in the study will receive either a new ‘stem-less’ prosthesis or a conventional one. The study will follow patients for two years after surgery to assess functional outcome, radiographic success (appearance on an X-ray) and absence of complications, revisions and adverse events.
To qualify, candidates must be at least 21 years old and have significant pain and functional impairments of the shoulder from a diagnosis of arthritis or avascular necrosis (death of bone tissue due to lack of blood supply). They must have also tried at least six months of non-surgical treatment, such as anti-inflammatory medications, physical therapy or steroid injections.
This trial is investigational, and it may not be appropriate for all patients. The safety and effectiveness of the Arthrex Eclipse is being investigated by this study and any benefit to patients has not been determined.
Arthrex, headquartered in Naples, Fla.,, is a leader in orthopaedic product development and medical education for orthopaedic surgeons.
To learn more about the clinical trial or about participating in the study, contact the Upstate Orthopedics Clinical Research Office, 315-464-8618.
Caption: Kevin J. Setter, MD, associate professor of orthopedic surgery, is leading Upstate’s participation in the study.