Clinical Trial

Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®

Not Yet Recruiting
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Summary
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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 * Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Trial Details
NCT Number NCT07663552
Lead Sponsor FX Solutions
Conditions Humeral Fracture, Proximal, Revision of a Shoulder Prosthesis
Enrollment 40 participants
Start Date 2026-07
Primary Completion 2036-12-31 (estimated)
Study Completion 2037-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-23