Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
NCT ID: NCT05703958
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
151 participants
OBSERVATIONAL
2023-04-19
2034-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing to agree to be followed for up to 10 years following their index surgery
* Patient is willing and able to review and sign a study informed consent form
Exclusion Criteria
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient has a physical or mental condition that would invalidate the results
21 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Responsible Party
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Principal Investigators
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Abhishek Ganta, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Grossman School of Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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CR21-001
Identifier Type: -
Identifier Source: org_study_id
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