RecruitingOsteo Arthritis ShouldersOsteonecrosisRotator Cuff Tears

Exactech Shoulder Post Market Clinical Follow-up Study

Eligible age

21+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Exactech

You may qualify if…

✓ 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

You may not qualify if…

✕ 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
✕ Non-functional deltoid muscles
✕ Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system