Research

A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex’s Eclipse™ Shoulder Prosthesis to the Univers™ II Shoulder Prosthesis in Patients with a Degenerative Joint Disease

A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex’s Eclipse™ Shoulder Prosthesis to the Univers™ II Shoulder Prosthesis in Patients with a Degenerative Joint Disease

This prospective, multicenter research study examines the clinical outcomes of individuals receiving the Arthrex Eclipse™  Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in those who are candidates for total shoulder replacement. Safety and effectiveness will be measured by a two year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.  Patient outcomes will be measured through use of the American Shoulder and Elbow Surgeons (ASES), Constant Score, SF-36, and Visual Analog Scale (VAS).  Additional information can be found at www.clinicaltrials.gov

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