Registry to evaluate outcomes of FX Shoulder replacement devices
Official title: FX Shoulder Post-Market Follow-Up Clinical Study
Run by FX Shoulder Solutions · NCT06078865 · Data updated 2026-11-12
This study is setting up a registry to see how well FX Shoulder replacement devices work for patients after their surgeries over the next few years.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | FX Shoulder Solutions Industry-sponsored |
| Locations | 4 sites (Gilbert, Arizona and 3 other locations) |
| Status | Recruiting |
| Started | March 31, 2021 |
| Main results expected | December 30, 2031 |
| Study ends | December 30, 2031 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT06078865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals scheduled to receive an FX shoulder replacement device due to conditions like osteoarthritis or rotator cuff syndrome.
✕Probably not a fit
Patients who do not qualify for FX shoulder replacement or have contraindications for the procedure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a multi-center registry to assess patient outcomes following shoulder replacement surgeries using FX Shoulder Solutions medical devices. It will evaluate the effectiveness, safety, and survivorship of these devices over a minimum follow-up period of two years, with continued monitoring for up to five years. The study will collect data to meet regulatory requirements and support future presentations and publications regarding the devices' performance.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of FX Shoulder replacement devices for patients with shoulder conditions.
How similar studies have gone: Other studies evaluating shoulder replacement devices have shown promising results, indicating that this approach is supported by existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system. Exclusion Criteria: Patient who does not meet the inclusion criteria.
Where it's running
-
OrthoArizona
Gilbert, Arizona, United States Recruiting -
First Settlement Orthopedics
Marietta, Ohio, United States Recruiting -
Orthopedics Rhode Island
Wakefield, Rhode Island, United States Recruiting -
Texas Orthopedic Specialists
Bedford, Texas, United States Recruiting
Study contacts
- Study coordinator: Brian Wasonga, MHA
- Email: bwasonga@fxshouldersolutions.com
- Phone: 800-280-0775
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating outcomes of FX Shoulder Solutions implants for shoulder conditions
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.
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Comparing two shoulder surgeries for older patients with osteoarthritis
This study is testing which shoulder surgery works better for older patients with severe arthritis: a total shoulder replacement or a reverse shoulder replacement.
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Evaluation of the PERFORM™ Humeral System for shoulder conditions
This study is testing how safe and effective the PERFORM™ Humeral System is for people who have had shoulder surgery by tracking their recovery and quality of life over the next ten years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.