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Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
Who can join
Ages 21 and older · All sexes
Full 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 Plate * Patient is willing to participate by complying with pre- and postoperative visit requirements * Patient is willing to agree to be followed for up to 10 years following their index surgery * Patient is willing and able to review and sign a study informed consent form Exclusion Criteria: * Osteomyelitis of the proximal humerus or scapula * Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * The patient is unwilling or unable to comply with the post-operative care instructions * Alcohol, drug, or other subtance abuse * Any disease state that could adversaly affect the function or longevity of the implant * Patient is pregnant * Patient is a prisoner * Patient has a physical or mental condition that would invalidate the results
About the study
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.
Sponsor: Exactech · Participants: 151 · Started: Apr 19, 2023
Contact the study team
- Rachael Craig · Phone: 1-833-423-8482
- Sandrine Angibaud · Phone: 1-833-423-8482
Official record on ClinicalTrials.gov — NCT05703958
Locations in the U.S.
| New York | NYU Grossman School of Medicine, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.