Vanderbilt Clinical Trials

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Purpose

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

Condition

Proximal Humeral Fracture

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts 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

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

Vanderbilt Orthopaedics
Nashville, Tennessee 37232

Contact:
Julie M Daniels
615-322-4506
Julie.M.Daniels@Vanderbilt.edu

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

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

Detailed Description

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.