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

Launched by EXACTECH · Jan 19, 2023

Keywords

ClinConnect Summary

The Exactech Proximal Humerus Fracture Plate System study is looking to gather information about the long-term safety and effectiveness of a specific type of surgery for shoulder fractures. This surgery uses a special plate to help heal the bone after an injury. The study aims to follow patients for up to 10 years after their surgery to see how well the implant works over time.

To be eligible for this trial, participants need to be scheduled to receive the Equinoxe Proximal Humerus Fracture Plate or have already had this surgery in the past. They should also be willing to attend follow-up appointments and sign consent forms for the study. Throughout the study, participants can expect regular check-ins to monitor their recovery and the performance of the implant. It’s important to note that certain conditions, like severe infections or other health issues, may disqualify individuals from participating. This study is open to all adults aged 18 and older.

Gender

ALL

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