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Subjects for Shoulder Osteoarthritis

N/A
Recruiting
Research Sponsored by FX Shoulder Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

Eligible Conditions
  • Shoulder Osteoarthritis
  • Shoulder Fracture
  • Rotator Cuff Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
Secondary outcome measures
Adjusted Constant Score
American Shoulder and Elbow Surgeon (ASES)
Device Related Adverse Events.
+7 more
Other outcome measures
Primary Effectiveness Endpoint

Trial Design

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 Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
FX Shoulder Solutions Retrospective / Prospective Clinical Study
2022. "FX Shoulder Solutions Retrospective / Prospective Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077942.
All > Tucson
~400 spots leftby Dec 2032
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