Clinical Outcomes of the ALPS Proximal Humerus Plating System

Study Overview
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Brief Summary
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The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. Specific Aims: Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions Document revisions, complications, and adverse events

Detailed Description
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The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. Specific Aims: Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions Document revisions, complications, and adverse events

Official Title
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Clinical Outcomes of the ALPS Proximal Humerus Plating System

Conditions
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Proximal Humeral Fracture

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System Patients who present with a proximal humerus fracture that involves the metaphysis 18 years or older Exclusion Criteria: Patients under the age of 18 Patients who have an infection, sepsis, or osteomyelitis Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support) Patients who do not speak English (do to unavailability of non-English surveys) Patients who have known risk factors of pathologic fractures (e.g. bone metastasis) Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years Patients who have Type 1 diabetes Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism) Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Proximal Humerus Fracture Patients<br>As part of their routine care, patients who have experienced a proximal humerus fracture that requires operative fixation will receive the A.L.P.S® Proximal Humerus Plating System. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Material Strength | Measured by the Osteoprobe | During surgical procedure | 
| Bone Indentation Distance | Measured by the Osteoprobe | During surgical procedure |