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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.
Eligible Conditions
- Shoulder Osteoarthritis
- Rotator Cuff Syndrome
- Shoulder Fracture
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS)
Survivorship
Secondary outcome measures
Adjusted Constant Score
American Shoulder and Elbow Surgeon (ASES)
QuickDASH
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SubjectsExperimental Treatment1 Intervention
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
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Who is running the clinical trial?
FX Shoulder SolutionsLead Sponsor
2 Previous Clinical Trials
690 Total Patients Enrolled
Brian Rogers, BSStudy DirectorFX Shoulder Solutions
2 Previous Clinical Trials
690 Total Patients Enrolled
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