Proximal Humeral FractureBones and joints
What this study is
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
Study details
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Proximal Humeral Fracture
- Enrolling
- 150 people
- Starts
- 2017-08-07
- Est. completion
- 2031-12-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt Orthopaedics
Nashville, Tennessee, United States
- Julie M Daniels · Contact615-322-4506Julie.M.Daniels@Vanderbilt.edu
- Mihir J Desai, MD · Principal investigator
Recruiting
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 171043
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.