Clinical Outcomes of the ALPS Proximal Humerus Plating System

Recruiting

• Conditions: Proximal Humeral Fracture

• Registration Number: NCT03328650
• Lead Sponsor: Vanderbilt University Medical Center

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2031-12-01
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Material Strength	During surgical procedure	Measured by the Osteoprobe
Bone Indentation Distance	During surgical procedure	Measured by the Osteoprobe

Trial Locations

Locations (1)

Vanderbilt Orthopaedics; 🇺🇸 Nashville, Tennessee, United States