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Recruiting NCT05703958

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Conditions: Proximal Humeral Fracture, Fracture Dislocation, Non-Union Fracture

Sex: All
Ages: 21 Years – N/A
Enrollment: 151
Sponsor: Exactech

Location: United States

Summary

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

Eligibility Criteria

Inclusion Criteria:Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture PlatePatient is willing to participate by complying with pre- and postoperative visit requirementsPatient is willing to agree to be followed for up to 10 years following their index surgeryPatient is willing and able to review and sign a study informed consent formExclusion Criteria:Osteomyelitis of the proximal humerus or scapulaInadequate or malformed bone that precludes adequate support or fixation of the prosthesisPatient's age, weight, or activity level would cause the surgeon to expect early failure of the systemThe patient is unwilling or unable to comply with the post-operative care instructionsAlcohol, drug, or other subtance abuseAny disease state that could adversaly affect the function or longevity of the implantPatient is pregnantPatient is a prisonerPatient has a physical or mental condition that would invalidate the results

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05703958). StuddyBuddy aggregates publicly available trial information.