FX Shoulder Solutions Retrospective / Prospective Clinical Study
Recruiting at 1 trial location
TM
BR
Overseen ByBrian Rogers, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Research Team
BR
Brian Rogers, BS
Principal Investigator
FX Shoulder Solutions
Eligibility Criteria
Inclusion Criteria
You have been provided with a FX Shoulder Solutions implant device, in agreement with the Indications for Use and based on your surgeon's evaluation and standard of care from January 1, 2018 to June 30, 2023.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Evaluation
Initial clinical evaluation and data collection following study enrollment
1 visit
1 visit (in-person)
Postoperative Evaluations
Successive evaluations at specified postoperative intervals to monitor outcomes and safety
10 years
Multiple visits at 3, 6, 12, 24 months, 5 and 10 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
10 years
Treatment Details
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SubjectsExperimental Treatment1 Intervention
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FX Shoulder Solutions
Lead Sponsor
Trials
3
Recruited
1,300+
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