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Retro-Prospective Postmarket Clinical Study For FX Shoulder Solutions Long Cemented HUMELOCK II®
Sponsor: FX Solutions
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2026-07
Completion Date
2037-06
Last Updated
2026-06-23
Healthy Volunteers
No
Interventions
Shoulder arthroplasty
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Locations (4)
CHU d' Angers
Angers, France
Hôpital privé Saint-Martin
Caen, France
Clinique Drouot Laffitte
Paris, France
Hôpital Nord
Saint-Priest-en-Jarez, France