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Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807
The purpose of this study is to collect device and procedure experience in everyday clinical practice. The patients are being asked to participate in this study because they are a surgical candidate for the treatment of a broken shoulder and are considering treatment with the PH Cage device.
The Conventus CAGE™ PH (PH Cage) System Post-Approval Prospective Study (Study) is a multi-center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice. Specifically, the study will provide: 1. Device safety and patient outcome data. 2. Device usage data. 3. Performance data for the implant procedure. 4. Publications. 5. Early economic benefit data. Patient Assessments Demographic and general health data will be collected on all patients at the baseline appointment to ensure subjects meet inclusion/exclusion criteria. In addition, to these data, x-rays and adverse event reports related to the implanted device, surgical procedure and/or study data collection methods will be collected. Patients will be seen at baseline, 2-, 6- and 12-week, 1- and 2-year post op. Patient participation in this study is voluntary. However, post-implant patient follow-up adds to the medical community's understanding of proximal humerus fracture patient outcomes, as well as the safety and performance of the PH Cage.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University Hospital
Redwood City, California, United States
Harbor-UCLA
Torrance, California, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Snug Harbor Orthopedics
Duxbury, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Start Date
February 1, 2018
Primary Completion Date
February 17, 2020
Completion Date
February 17, 2020
Last Updated
February 20, 2020
40
ACTUAL participants
Conventus Cage™ PH
DEVICE
Lead Sponsor
Conventus Orthopaedics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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