Clinical Outcomes of the ALPS Proximal Humerus Plating System

NCT03328650 | Recruiting

• 1 other identifier: 171043
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (2)

• Bone Material Strength

  Measured by the Osteoprobe

  During surgical procedure

• Bone Indentation Distance

  Measured by the Osteoprobe

  During surgical procedure

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Orthopaedics

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Julie M Daniels

CONTACT

615-322-4506; Julie.M.Daniels@Vanderbilt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery and Rehabilitation

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: November 1, 2017
• Study Start: August 7, 2017
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)