NCT06078865

FX Shoulder Prospective Clinical Study

FX Shoulder Post-Market Follow-Up Clinical Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: FX Shoulder Solutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

Detailed description

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices. To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements. To provide data and analysis for presentations, abstracts, publications and other public release of results. A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS): * Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline * No continuous radiolucency or device migration/subsidence * No revision surgery * No serious device related adverse event The Registry will continue to follow patients to 10 years post-operative to track survivorship.

Conditions

• Osteoarthritis Shoulder
• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Fracture, Shoulder

Interventions

Type	Name	Description
DEVICE	FX Artificial Shoulder Prosthesis	Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System

Timeline

• Start date: 2021-03-31
• Primary completion: 2031-12-30
• Completion: 2031-12-30
• First posted: 2023-10-12
• Last updated: 2026-02-09

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study