Clinical Outcomes of the ALPS Proximal Humerus Plating System

NCT ID: NCT03328650

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-07
• Study Completion Date: 2031-12-01

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

Conditions

Proximal Humeral Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mihir Desai

Assistant Professor of Orthopaedic Surgery and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt Orthopaedics

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie M Daniels

Role: CONTACT

Julie.M.Daniels@Vanderbilt.edu

615-322-4506

Facility Contacts

Julie M Daniels

Role: primary

Julie.M.Daniels@Vanderbilt.edu

615-322-4506

Other Identifiers

171043

Identifier Type: -

Identifier Source: org_study_id