NCT03328650 Clinical Outcomes of the ALPS Proximal Humerus Plating System
| NCT ID | NCT03328650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Proximal Humeral Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2017-08-07 |
| Primary Completion | 2031-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2017-08-07 with a primary completion date of 2031-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03328650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Proximal Humeral Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03328650 currently recruiting?
Yes, NCT03328650 is actively recruiting participants. Contact the research team at Julie.M.Daniels@Vanderbilt.edu for enrollment information.
Where is the NCT03328650 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT03328650 clinical trial?
NCT03328650 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 150 participants.