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

Recruiting now

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT07558590

Run by

FX Solutions

People needed

1004

Starts

2020-06-01

Expected to finish

2037-06-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Neurological pathologies compromising the shoulder stability
• Morbid obesity
• Muscular deficiencies impairing the shoulder joint

Where it is running

• CHU Amiens Picardie — Amiens, France (enrolling)
• CHU d' Angers — Angers, France (enrolling)
• Hôpital Jean Minjoz — Besançon, France (enrolling)
• Clinique Aguiléra — Biarritz, France (enrolling)
• Hôpital privé Saint-Martin — Caen, France (enrolling)
• Infirmerie Protestante — Caluire-et-Cuire, France (enrolling)
• CHMS Chambéry — Chambéry, France (enrolling)
• HÔPITAUX CIVILS de Colmar — Colmar, France (enrolling)
• Hôpital privé Dijon Bourgogne — Dijon, France (enrolling)
• Clinique Saint Charles — La Roche-sur-Yon, France (enrolling)
• Clinique chirurgicale Porte Océane — Les Sables-d'Olonne, France (enrolling)
• Clinique Saint Charles — Lyon, France (enrolling)
• L'hôpital privé du confluent — Nantes, France (enrolling)
• Hopital Bichat — Paris, France (enrolling)
• Clinique des Maussins — Paris, France (enrolling)
• Pavillon de la Mutualite — Pessac, France (enrolling)
• Clinique Saint Michel et Sainte Anne — Quimper, France (enrolling)
• Clinique Mutualiste — Saint-Etienne, France (enrolling)
• Polyclinique de l'Atlantique — Saint-Herblain, France (enrolling)
• C. H. St- Nazaire — Saint-Nazaire, France (enrolling)
• Clinique de l'Orangerie — Strasbourg, France (enrolling)
• Centre Hospitalier Princesse Grace — Monaco, Monaco (enrolling)

Full record on ClinicalTrials.gov

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