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Clinical Outcomes of the ALPS Proximal Humerus Plating System
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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
Sponsor: Vanderbilt University Medical Center · Participants: 150 · Started: Aug 7, 2017
Contact the study team
- Julie M Daniels · Phone: 615-322-4506
Official record on ClinicalTrials.gov — NCT03328650
Locations in the U.S.
| Tennessee | Vanderbilt Orthopaedics, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.