Exactech Shoulder Post Market Clinical Follow-up Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorExactech

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

Trial groups

No trial groups listed

Sponsors and collaborators