Clinical Trial

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

Recruiting
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Summary
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term. Secondary objectives are * Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation
Trial Details
NCT Number NCT07558590
Lead Sponsor FX Solutions
Conditions Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear, Rotator Cuff Arthropathy, Inflammatory Arthritis, Revision of a Shoulder Prosthesis
Enrollment 1,004 participants
Start Date 2020-06-01
Primary Completion 2036-12-31 (estimated)
Study Completion 2037-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-30