Clinical Outcomes of the ALPS Proximal Humerus Plating System

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Oct 27, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at a special treatment for patients with proximal humeral fractures, which are breaks near the top of the upper arm bone. The study focuses on the A.L.P.S® Proximal Humerus Plating System, a device used to help fix these fractures. Researchers want to understand how well this treatment works by checking shoulder strength, movement, and how much pain patients feel. They will also collect feedback from patients about their ability to perform daily activities and any issues they experience after the surgery.

To participate in the trial, you need to be at least 18 years old and have a specific type of shoulder fracture that requires this plating system. However, the study cannot accept patients under 18, those with certain infections, or individuals who may have difficulty with follow-up care. If you decide to join, you can expect regular assessments of your shoulder's performance and to share your experiences regarding pain and functionality. This trial is currently recruiting participants, and all genders are welcome.

Gender

ALL

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