Clinical Outcomes of the ALPS Proximal Humerus Plating System
Recruiting now
Conditions studied: Proximal Humeral Fracture
In brief
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
Key facts
- Study ID
- NCT03328650
- Run by
- Vanderbilt University Medical Center
- People needed
- 150
- Starts
- 2017-08-07
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vanderbilt Orthopaedics — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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