RecruitingNCT03328650

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Sponsor

Vanderbilt University Medical Center

Enrollment

150 participants

Start Date

Aug 7, 2017

Study Type

OBSERVATIONAL

Conditions

Proximal Humeral Fracture

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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
years or older

Exclusion Criteria9

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

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