Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
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 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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov