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
1004 cases are planned to be included in 11 groups of implants (range, indication and constructs). Recruitment of patients can be retrospective or prospective, preferrably prospective. Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
Study Type
OBSERVATIONAL
Enrollment
1,004
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
CHU Amiens Picardie
Amiens, France
RECRUITINGCHU d' Angers
Angers, France
RECRUITINGHôpital Jean Minjoz
Besançon, France
RECRUITINGClinique Aguiléra
Biarritz, France
RECRUITINGHôpital privé Saint-Martin
Caen, France
RECRUITINGInfirmerie Protestante
Caluire-et-Cuire, France
RECRUITINGCHMS Chambéry
Chambéry, France
RECRUITINGHÔPITAUX CIVILS de Colmar
Colmar, France
RECRUITINGHôpital privé Dijon Bourgogne
Dijon, France
RECRUITINGClinique Saint Charles
La Roche-sur-Yon, France
RECRUITING...and 12 more locations
Revision rate (KM) at 10 years postoperative
Time frame: at the end of the postoperative follow-up period of 10 years
Revision rate (KM) at each post-operative visits
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)
Range of Motions at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
QuickDASH score at each follow-up visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Constant-Murley score at each follow-up visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
ASES score at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
VAS pain at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
SSV score at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Radiological assessment of implant positioning at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Incidence of complications at each postoperative visit
Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
Qualitative feedback on the instrumentation
Time frame: at surgery reporting
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