Clinical Outcomes of the ALPS Proximal Humerus Plating System

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03328650
Status
Recruiting
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Conditions

  • Proximal Humeral Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Aug 7, 2017
Status verified
May 2026
Primary completion
Dec 1, 2031
Completion
Dec 1, 2031

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Bone Material Strength [ Time Frame: During surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt OrthopaedicsNashvilleTennessee37232
Julie M Daniels
[email protected]
615-322-4506
Mihir J Desai, MD (PRINCIPAL_INVESTIGATOR)

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Vanderbilt Orthopaedics· Nashville, TN

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