RECRUITING

Clinical Outcomes of the ALPS Proximal Humerus Plating System

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Conditions

Proximal Humeral Fracture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Quick Facts

Study Start:2017-08-07
Study Completion:2031-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03328650

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System
  2. * Patients who present with a proximal humerus fracture that involves the metaphysis
  3. * 18 years or older
  1. * Patients under the age of 18
  2. * Patients who have an infection, sepsis, or osteomyelitis
  3. * 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)
  4. * Patients who do not speak English (do to unavailability of non-English surveys)
  5. * Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
  6. * Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years
  7. * Patients who have Type 1 diabetes
  8. * Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
  9. * Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Vanderbilt Orthopaedics
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-07
Study Completion Date2031-12-01

Study Record Updates

Study Start Date2017-08-07
Study Completion Date2031-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Proximal Humeral Fracture