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Observational Study of the ALPS Proximal Humerus Plating System

This study is looking at how well the A.L.P.S. Proximal Humerus Plating System works for people who have broken their upper arm bone (proximal humerus fracture). Researchers want to see how this plating system performs in real-world use. They will be checking things like your shoulder strength and movement, looking at X-rays, and asking you about your pain levels and how well you can do daily activities. They will also keep track of any complications or if the plate needs to be revised. You might be able to join if you are 18 or older and need surgery for a proximal humerus fracture using this specific plating system. The study aims to enroll 150 people, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information about people who receive the A.L.P.S. Proximal Humerus Plating System. The study plans to include 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures bone material strength and bone indentation distance during the surgical procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03328650

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Recruiting
Not specifiedAges 18+Observational
Vanderbilt University Medical Center
~150 participants
Updated 2026-05-11 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bone Material Strength
Measured over During surgical procedure
+1 more outcome measured

Conditions

Proximal Humeral Fracture

Explore related trials

Shoulder Fracture

NCT03328650

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Vanderbilt Orthopaedics

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Julie M Daniels
[email protected]
615-322-4506
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Bone Material StrengthDuring surgical procedure

    Measured by the Osteoprobe

  • Bone Indentation DistanceDuring surgical procedure

    Measured by the Osteoprobe