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
59 participants
OBSERVATIONAL
2025-06-19
2040-12-31
Brief Summary
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Detailed Description
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The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Treatment Group
The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.
Comprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Interventions
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Comprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Eligibility Criteria
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Inclusion Criteria
* Patient must be willing and able to follow directions.
* Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem
Exclusion Criteria
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
* Patient is unwilling to sign informed consent.
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
18 Years
100 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Boylan, MBA
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Aalborg University Hospital
Aalborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDRG2017-89MS-50E
Identifier Type: -
Identifier Source: org_study_id
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