Registry to evaluate outcomes of FX Shoulder replacement devices
FX Shoulder Post-Market Follow-Up Clinical Study
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | FX Shoulder Solutions Industry-sponsored |
| Locations | 4 sites (Gilbert, Arizona and 3 other locations) |
| Trial ID | NCT06078865 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled to receive an FX shoulder replacement device due to conditions like osteoarthritis or rotator cuff syndrome.
Not a fit: Patients who do not qualify for FX shoulder replacement or have contraindications for the procedure may not benefit from this study.
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 performed: Other studies evaluating shoulder replacement devices have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
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 this trial is running
Gilbert, Arizona and 3 other locations
- 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
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.