NCT05603728
Exactech Shoulder Post Market Clinical Follow-up Study
Recruiting · Not specified · Exactech · registry updated 2026-09-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- Patient is willing and able to read and sign a study informed consent form
Exclusion
- 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
- Neuromuscular disorders that do not allow control of the joint
- Significant injury to the brachial plexus