Clinical Outcomes of the ALPS Proximal Humerus Plating System

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

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Study Overview

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Study Details

Study overview

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

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Condition
Proximal Humeral Fracture
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt Orthopaedics, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Study Record Dates

2031-12-01