FX Shoulder Solutions
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Osteoarthritis Shoulder
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Fracture, Shoulder
FX Artificial Shoulder Prosthesis
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices. 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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 600 participants |
| Official Title : | FX Shoulder Post-Market Follow-Up Clinical Study |
| Actual Study Start Date : | 2021-03-31 |
| Estimated Primary Completion Date : | 2027-12-30 |
| Estimated Study Completion Date : | 2027-12-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
OrthoArizona
Gilbert, arizona, United States, 85297
RECRUITING
First Settlement Orthopedics
Marietta, Ohio, United States, 45750
RECRUITING
Orthopedics Rhode Island
Wakefield, Rhode Island, United States, 02879
RECRUITING
Texas Orthopedic Specialists
Bedford, Texas, United States, 76021