---
title: Clinical Outcomes of the ALPS Proximal Humerus Plating System
nct_id: NCT03328650
overall_status: RECRUITING
sponsor: Vanderbilt University Medical Center
study_type: OBSERVATIONAL
primary_condition: Proximal Humeral Fracture
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03328650.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03328650"
ct_last_update_post_date: 2026-05-11
last_seen_at: "2026-05-12T06:04:08.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Outcomes of the ALPS Proximal Humerus Plating System

**NCT ID:** [NCT03328650](https://clinicaltrials.gov/study/NCT03328650)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Vanderbilt University Medical Center
- **Conditions:** Proximal Humeral Fracture
- **Start Date:** 2017-08-07
- **Completion Date:** 2031-12-01
- **CT.gov Last Update:** 2026-05-11

## 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

## Detailed Description

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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Proximal Humerus Fracture Patients** — As part of their routine care, patients who have experienced a proximal humerus fracture that requires operative fixation will receive the A.L.P.S® Proximal Humerus Plating System. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes.

## Primary Outcomes

- **Bone Material Strength** _(time frame: During surgical procedure)_ — Measured by the Osteoprobe
- **Bone Indentation Distance** _(time frame: During surgical procedure)_ — Measured by the Osteoprobe

## Locations (1)

- Vanderbilt Orthopaedics, Nashville, Tennessee, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.vanderbilt orthopaedics|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03328650.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03328650*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*