Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03328650

Clinical Outcomes of the ALPS Proximal Humerus Plating System

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Orthopaedics

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Julie M Daniels

CONTACT

[email protected]

615-322-4506

Mihir J Desai, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bone Material Strength

    Time frame: During surgical procedure

    Measured by the Osteoprobe

  2. Bone Indentation Distance

    Time frame: During surgical procedure

    Measured by the Osteoprobe

Study contacts

Contact information is provided by the study sponsor or research team.

Julie M Daniels

CONTACT

[email protected]

615-322-4506

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: ALPS PHP

Important dates

Study start
2017
Primary completion
2031
Study completion
2031
First posted
Nov 1, 2017
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.