Evaluating outcomes of FX Shoulder Solutions implants for shoulder conditions
FX Shoulder Solutions Retrospective / Prospective Clinical Study
This study is testing how well FX Shoulder Solutions implants work for people who have had shoulder replacement surgeries to see if they help patients recover safely and effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | FX Shoulder Solutions Industry-sponsored |
| Locations | 2 sites (Gilbert, Arizona and 1 other locations) |
| Trial ID | NCT06077942 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate patient outcomes following shoulder replacement surgeries using FX Shoulder Solutions medical devices. It will collect both retrospective and prospective clinical data, including demographics, baseline medical status, surgical procedures, and postoperative evaluations. The study seeks to demonstrate the effectiveness, safety, and survivorship of these implants while providing necessary data for regulatory compliance and future presentations. Patient consent is required for enrollment, and evaluations will occur at specified postoperative intervals.
Who should consider this trial
Good fit: Ideal candidates are patients who have received an FX Shoulder Solutions replacement device between January 1, 2018, and June 30, 2023.
Not a fit: Patients who have not received an FX Shoulder Solutions replacement device or do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the effectiveness and safety of FX Shoulder Solutions implants, potentially improving patient outcomes in shoulder surgeries.
How similar studies have performed: While this study focuses on a specific brand of shoulder implants, similar observational studies have shown success in evaluating outcomes of shoulder replacements, indicating a potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patient who does not meet the inclusion criteria above
Where this trial is running
Gilbert, Arizona and 1 other locations
- OrthoArizona — Gilbert, Arizona, United States (Not_yet_recruiting)
- Advanced Orthopedics Institute — The Villages, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Ted McKittrick, BA
- Email: tmckittrick@fxshouldersolutions.com
- Phone: 7242493364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.