The purpose of this study is to evaluate the long-term performance and safety of a device called the Integra Titan Modular Shoulder System 2.5 for Primary Total Shoulder Joint Replacement (also called the "Titan 2.5"). The study focuses on individuals who have severely painful and/or disabled joints resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis, or who have serious fractures of the humerus (the long bone in the upper half of the arm) and will undergo primary shoulder replacement surgery using the Titan-2.5 as standard of care for their condition. The Titan 2.5 is approved for shoulder replacement surgery by the U.S. Food and Drug Administration (FDA). It is designed to treat pain, limited motion, or weakness in the shoulder. The device works by replacing the diseased shoulder joint of patients.
Full Title
A POST-MARKET, PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER, OPEN-LABEL CLINICAL EVALUATION OF THE INTEGRA® TITAN MODULAR SHOULDER SYSTEM 2.5 FOR PRIMARY SHOULDER JOINT REPLACEMENT