Actively Recruiting
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Led by Vanderbilt University Medical Center · Updated on 2026-05-11
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are documenting the performance and clinical outcomes of the A.L.P.S4 Proximal Humerus Plating System in patients who have experienced a proximal humerus fracture requiring surgery. The study aims to measure shoulder strength and range of motion, assess radiographs by physicians, gather patient feedback on pain, functional abilities, and work or leisure restrictions, and record any revisions, complications, or adverse events. Patients receiving routine care for proximal humerus fractures needing operative fixation will be treated with the A.L.P.S4 Proximal Humerus Plating System. This is an observational, prospective study that monitors patients' pain levels, functional capabilities, and outcomes reported directly by the patients themselves. Participants will undergo physical assessments to evaluate shoulder strength and motion, and physicians will review radiographs. Patient-reported outcomes will be collected to understand pain and activity limitations. Researchers will track any adverse events or surgical revisions throughout the study period. Key primary measures include bone material strength and bone indentation distance taken during the surgical procedure.
CONDITIONS
Brief Title
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have a proximal humerus fracture requiring primary or revision ORIF using the A.L.P.S Proximal Humerus Plating System
- Patients with a proximal humerus fracture involving the metaphysis
- Adults aged 18 years or older
You will not qualify if you...
- Patients under 18 years of age
- Patients with infection, sepsis, or osteomyelitis
- Patients unwilling or unable to participate or maintain follow-up, including those with certain psychiatric disorders, prisoners, homeless individuals, or those without adequate family support
- Patients who do not speak English
- Patients with known risk factors for pathologic fractures such as bone metastasis
- Patients treated for osteoporosis within the last 5 years or for longer than 5 years
- Patients with Type 1 diabetes
- Patients with other bone diseases such as osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, or hyperparathyroidism
- Patients with a history of cancer, abnormal serum calcium, or chronic steroid use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 10 years until study completion
Participants who undergo routine care with the A.L.P.S® Proximal Humerus Plating System are observed for clinical outcomes including pain, functional ability, and patient-reported outcomes.
Multiple follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
Vanderbilt Orthopaedics
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
J
Julie M Daniels
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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