Clinical Outcomes of the ALPS Proximal Humerus Plating System

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03328650

Acronym

ALPS PHP

Enrollment

150

Registered

2017-11-01

Start date

2017-08-07

Completion date

2031-12-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fracture

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Bone Material Strength	During surgical procedure	Measured by the Osteoprobe
Bone Indentation Distance	During surgical procedure	Measured by the Osteoprobe

Countries

United States

Contacts

CONTACTJulie M Daniels

Julie.M.Daniels@Vanderbilt.edu615-322-4506

Outcome results