NCT06077942

FX Shoulder Solutions Retrospective / Prospective Clinical Study

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

Summary

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

Detailed description

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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. Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study. Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.

Conditions

• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Osteoarthritis Shoulder
• 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, PRCT II Fracture Plate, V-135

Timeline

• Start date: 2022-12-06
• Primary completion: 2032-12-30
• Completion: 2032-12-30
• First posted: 2023-10-11
• Last updated: 2023-10-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study