Actively Recruiting
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
Led by FX Solutions · Updated on 2026-04-30
1004
Participants Needed
22
Research Sites
887 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems according to its instructions for use and surgical technique
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and consented to participate in the study
You will not qualify if you...
- Neurological pathologies compromising shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 22 locations
1
CHU Amiens Picardie
Amiens, France, 80054
Actively Recruiting
2
CHU d' Angers
Angers, France, 49933
Actively Recruiting
3
Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
4
Clinique Aguiléra
Biarritz, France, 64200
Actively Recruiting
5
Hôpital privé Saint-Martin
Caen, France, 14000
Actively Recruiting
6
Infirmerie Protestante
Caluire-et-Cuire, France, 69300
Actively Recruiting
7
CHMS Chambéry
Chambéry, France, 73011
Actively Recruiting
8
HÔPITAUX CIVILS de Colmar
Colmar, France, 68024
Actively Recruiting
9
Hôpital privé Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
10
Clinique Saint Charles
La Roche-sur-Yon, France, 85016
Actively Recruiting
11
Clinique chirurgicale Porte Océane
Les Sables-d'Olonne, France, 85101
Actively Recruiting
12
Clinique Saint Charles
Lyon, France, 69001
Actively Recruiting
13
L'hôpital privé du confluent
Nantes, France, 44277
Actively Recruiting
14
Hopital Bichat
Paris, France, 75018
Actively Recruiting
15
Clinique des Maussins
Paris, France, 75020
Actively Recruiting
16
Pavillon de la Mutualite
Pessac, France, 33608
Actively Recruiting
17
Clinique Saint Michel et Sainte Anne
Quimper, France, 29000
Actively Recruiting
18
Clinique Mutualiste
Saint-Etienne, France, 42000
Actively Recruiting
19
Polyclinique de l'Atlantique
Saint-Herblain, France, 44819
Actively Recruiting
20
C. H. St- Nazaire
Saint-Nazaire, France, 44606
Actively Recruiting
21
Clinique de l'Orangerie
Strasbourg, France, 67000
Actively Recruiting
22
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Actively Recruiting
Research Team
K
Kathy TRIER, PhD
CONTACT
G
Gabriel GUEUGNON
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
11
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