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
600 participants
OBSERVATIONAL
2021-03-31
2027-12-30
Brief Summary
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Detailed Description
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To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.
To provide data and analysis for presentations, abstracts, publications and other public release of results.
A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):
* Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9
* No continuous radiolucency or device migration/subsidence
* No revision surgery
* No serious device related adverse event
The Registry will continue to follow patients to 5 years post-operative to track survivorship.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
FX Artificial Shoulder Prosthesis
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System,Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135
Interventions
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FX Artificial Shoulder Prosthesis
Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System,Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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FX Shoulder Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Rogers, BS
Role: STUDY_DIRECTOR
FX Shoulder Solutions
Locations
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OrthoArizona
Gilbert, Arizona, United States
First Settlement Orthopedics
Marietta, Ohio, United States
Orthopedics Rhode Island
Wakefield, Rhode Island, United States
Texas Orthopedic Specialists
Bedford, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FXShoulder2020-1
Identifier Type: OTHER
Identifier Source: secondary_id
FXShoulder2020-01
Identifier Type: -
Identifier Source: org_study_id
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