The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
Patient is skeletelly mature
Patient is expected to survive at least 2 years beyond surgery
Patient is willing to participate by complying with pre- and postoperative visit requirements
Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
Medial humeral bone loss resulting in compromised humeral stem fixation
Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Cohort
Other
Not listed
Constant
Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
ASES
American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
Oxford Score (may be used as an optional form for surgeons in the United Kingdom)
Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability
TESS (may be used as specific forms related to the pre-operative condition/diagnosis)
Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
