RecruitingNCT05703958

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

Sponsor

Exactech

Enrollment

151 participants

Start Date

Apr 19, 2023

Study Type

OBSERVATIONAL

Conditions

Proximal Humeral Fracture Fracture Dislocation Non-Union Fracture

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

Min Age: 21 Years

Inclusion Criteria4

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 Criteria9

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

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