Status:
RECRUITING
FX Shoulder Solutions Retrospective / Prospective Clinical Study
Lead Sponsor:
FX Shoulder Solutions
Conditions:
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Osteoarthritis Shoulder
Eligibility:
All Genders
Brief Summary
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Detailed Description
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices To...
Eligibility Criteria
Inclusion
- Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.
Exclusion
- Patient who does not meet the inclusion criteria above
Key Trial Info
Start Date :
December 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2032
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06077942
Start Date
December 6 2022
End Date
December 30 2032
Last Update
October 12 2023
Active Locations (2)
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1
OrthoArizona
Gilbert, Arizona, United States, 85297
2
Advanced Orthopedics Institute
The Villages, Florida, United States, 32159