The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
Study Type
OBSERVATIONAL
Enrollment
118
Florida Orthopedic Institute
Tampa, Florida, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Vanderbilt Hand Center
Nashville, Tennessee, United States
American Shoulder and Elbow Society Score (ASES) Pain Assessment
This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Time frame: 5 years
Patient Derived American Shoulder and Elbow Society Score (ASES) Function
This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.
Time frame: 5 Years
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction
This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.
Time frame: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs
This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.
Time frame: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability
Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.
Time frame: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength
Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
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Time frame: 5 Years
Incidence of Surviving Elbows
Proportion of elbows that did not require revision or removal
Time frame: Up to 5 Years