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

Exactech

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05703958

CR21-001

Details and patient eligibility

About

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.

Enrollment: 151 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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