Clinical Outcomes of the ALPS Proximal Humerus Plating System (NCT03328650) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Outcomes of the ALPS Proximal Humerus Plating System
United States150 participantsStarted 2017-08-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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