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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes

Conditions
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Proximal Humeral Fracture, Fracture Dislocation, Non-Union Fracture

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smart Score | Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score | Through study completion, an average of 1 per year | 
| Sane Score | Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal | Through study completion, an average of 1 per year | 
| ASES | American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition | Through study completion, an average of 1 per year | 
| Quick DASH | Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable | Through study completion, an average of 1 per year |