About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed