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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
CHU d' Angers
RECRUITING
Angers
Hôpital Jean Minjoz
RECRUITING
Besançon
Clinique Aguiléra
RECRUITING
Biarritz
Hôpital privé Saint-Martin
RECRUITING
Caen
Infirmerie Protestante
RECRUITING
Caluire-et-cuire
CHMS Chambéry
RECRUITING
Chambéry
HÔPITAUX CIVILS de Colmar
RECRUITING
Colmar
Hôpital privé Dijon Bourgogne
RECRUITING
Dijon
Clinique Saint Charles
RECRUITING
La Roche-sur-yon
Clinique chirurgicale Porte Océane
RECRUITING
Les Sables-d'olonne
Clinique Saint Charles
RECRUITING
Lyon
L'hôpital privé du confluent
RECRUITING
Nantes
Clinique des Maussins
RECRUITING
Paris
Hopital Bichat
RECRUITING
Paris
Pavillon de la Mutualite
RECRUITING
Pessac
Clinique Saint Michel et Sainte Anne
RECRUITING
Quimper
Clinique Mutualiste
RECRUITING
Saint-etienne
Polyclinique de l'Atlantique
RECRUITING
Saint-herblain
C. H. St- Nazaire
RECRUITING
Saint-nazaire
Clinique de l'Orangerie
RECRUITING
Strasbourg
Monaco
Centre Hospitalier Princesse Grace
RECRUITING
Monaco
Contact Information
Primary
Kathy TRIER, PhD
ktrier@fxshouldersolutions.com
800-280-0775
Backup
Gabriel GUEUGNON
ggueugnon@fxshouldersolutions.com
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2037-06
Participants
Target number of participants: 1004
Treatments
Group 1: HUMELOCK II® TSA
Subjects treated with HUMELOCK II® Anatomic Shoulder System
Group 21: cementless HUMELOCK II® RSA - trauma
Subjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications
Group 22: cemented long HUMELOCK II® RSA - revision
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
Group 31: SHUMELOCK REVERSED® - degenerative
Subjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications
Group 32: HUMELOCK REVERSED® - trauma
Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications
Group 4: cementless HUMERIS® Anatomic - degenerative
Subjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications
Group 5: cementless HUMERIS® RSA - degenerative
Subjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications
Group 6: EASYTECH® TSA - degenerative
Subjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications
Group 7: EASYTECH® RSA - revision
Subjects treated with EASYTECH® Reversible Shoulder System for revision indications
Group 8: EASYTECH® RSA - degenerative
Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications
Group 33: HUMELOCK REVERSED® - revision
Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications
Related Therapeutic Areas
Sponsors
Leads: FX Solutions

This content was sourced from clinicaltrials.gov