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

Recruiting Observational Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,004 (estimated)
Sponsor
FX Solutions · Industry
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About This Trial
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 o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique. * Patient aged 18 years and above * Patient insured with a social security system * Has been informed and did consent to parti…
Contacts

Kathy TRIER, PhD

800-280-0775

ktrier@fxshouldersolutions.com

CONTACT

Gabriel GUEUGNON

ggueugnon@fxshouldersolutions.com

CONTACT