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Status:

RECRUITING

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Lead Sponsor:

Vanderbilt University Medical Center

Conditions:

Proximal Humeral Fracture

Eligibility:

All Genders

18+ years

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 stren...

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 stren...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 7 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2031

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03328650

Start Date

August 7 2017

End Date

December 1 2031

Last Update

April 1 2025

Active Locations (1)

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Vanderbilt Orthopaedics

Nashville, Tennessee, United States, 37232