Eclipse Shoulder Surgery Clinical Trial
DR. COHEN TO “ECLIPSE” THE FUTURE OF SHOULDER SURGERY
Adena Orthopedic Surgeon Dr. Brain Cohen has always been at the forefront when it comes to shoulder replacement procedures, and now he is set to begin the first-ever clinical trial in Adena Health System’s 120-plus year history.
“The future of shoulder replacement will be stemless,” Dr. Cohen explains, referring to the Eclipse shoulder prosthesis.
The Eclipse, developed by Arthrex, uses a hollow screw system as the implant into the patient’s humerus bone, opposed to the long stem component typically found in a Univers II prosthesis.
Over 10,000 Eclipse devices have been implanted in Europe and Canada; and only in the last year and a half has this new stemless technology been available in the United States. Here, the device is only being used in clinical trials as it waits for FDA approval. The clinical trial includes 350 patients treated by a group of shoulder specialist, of which Dr. Cohen is included. These practitioners are considered experts in the field of total shoulder replacement. Currently, there are fewer than 15 surgeons in the U.S. participating in the Eclipse trial.
“We started this process about a year ago - to bring this to Adena,” said Dr. Cohen. “The results from those patients receiving the Eclipse over in Europe have been very good, and we are looking for results of our clinical trial to be equal to or better than the outcome patients receive with the Univers II component.”
Over the past three decades, severe shoulder arthritis has been treated with stemmed total shoulder replacement devices. Stemmed total shoulder replacements have been considered the “standard” of surgical treatment for severe shoulder arthritis. The benefit of going to a stemless Eclipse prosthesis is it is a bone preserving technology. This means less surgery time for the patient, less blood loss, reduced chance of nerve damage and bone fracture, and fewer risks for other complications. The Eclipse surgery is the same as a surgery with the Univers II implant, and recovery time and rehab are similar as well. This is a result of both procedures requiring the healing of muscles, ligaments and tendons following surgery.
The reason for the clinical trial is to evaluate the Eclipse shoulder prosthesis compared to the Univers II prosthesis. The Eclipse device system was designed to preserve more healthy bone in the humerus. Saving more healthy bone and tissue may also reduce pain, make the new joint function more naturally and maintain options in the unlikely event that future surgery is needed.
Participants in the trial are randomly selected to receive either the Eclipse device or the standard Univers II treatment in a 2:1 ratio. The study will follow participants for two years after surgery to assess functional outcomes, radiographic success, need for surgical revisions or adverse effects.
Dr. Cohen’s work has made Adena Health System and Adena Bone & Joint Center a name recognized both nationally and internationally. His continued efforts to strive for the best in patient care using the latest technology and practices is only matched by the results his patients receive.
Are you considering a total shoulder replacement?
Are you 21 or older and suffering from shoulder pain that affects your daily life?
Have you received at least six months of therapy or treatment for your painful shoulder?
Have you been told you have osteoarthritis, avascular necrosis, post-traumatic arthritis or rheumatoid arthritis in your shoulder?
If you answered “yes” to the above questions, you may be eligible to participate in a Clinical Research Study.
Call today for more information!Adena Bone & Joint Center740-779-4598
Participants will receive monetary compensation for their time. All study-related procedures will either be billed to your insurance or covered by the sponsor.
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