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

Recruitingn/aAges 18 Years - anyAllFX Solutions
NCT07558590 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 participate to the study. Exclusion Criteria: * Neurological pathologies compromising the shoulder stability * Morbid obesity * Muscular deficiencies impairing the shoulder joint
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What it tests

  • Shoulder arthroplasty
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Where

22 sites
CHU Amiens Picardie
Amiens, France
CHU d' Angers
Angers, France
Hôpital Jean Minjoz
Besançon, France
Clinique Aguiléra
Biarritz, France
Hôpital privé Saint-Martin
Caen, France
Infirmerie Protestante
Caluire-et-Cuire, France
CHMS Chambéry
Chambéry, France
HÔPITAUX CIVILS de Colmar
Colmar, France

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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