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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01279-48 | Other Identifier | ANSM |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Group 32: HUMELOCK REVERSED® - trauma | Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications |
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| Group 4: cementless HUMERIS® Anatomic - degenerative |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder arthroplasty | Procedure | Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate (KM) at 10 years postoperative | at the end of the postoperative follow-up period of 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate (KM) at each post-operative visits | 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 | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Study population is issued from investigators' patient population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy TRIER, PhD | Contact | 800-280-0775 | ktrier@fxshouldersolutions.com | |
| Gabriel GUEUGNON | Contact | ggueugnon@fxshouldersolutions.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | 80054 | France |
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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 |
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| Group 7: EASYTECH® RSA - revision | Subjects treated with EASYTECH® Reversible Shoulder System for revision indications |
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| Group 8: EASYTECH® RSA - degenerative | Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications |
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| Group 33: HUMELOCK REVERSED® - revision | Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications |
|
| QuickDASH score at each follow-up visit | 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 | 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 | 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 | 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 | 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 | 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 | 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 | at surgery reporting |
| CHU d' Angers | Recruiting | Angers | 49933 | France |
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| Hôpital Jean Minjoz | Recruiting | Besançon | 25030 | France |
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| Clinique Aguiléra | Recruiting | Biarritz | 64200 | France |
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| Hôpital privé Saint-Martin | Recruiting | Caen | 14000 | France |
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| Infirmerie Protestante | Recruiting | Caluire-et-Cuire | 69300 | France |
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| CHMS Chambéry | Recruiting | Chambéry | 73011 | France |
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| HÔPITAUX CIVILS de Colmar | Recruiting | Colmar | 68024 | France |
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| Hôpital privé Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
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| Clinique Saint Charles | Recruiting | La Roche-sur-Yon | 85016 | France |
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| Clinique chirurgicale Porte Océane | Recruiting | Les Sables-d'Olonne | 85101 | France |
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| Clinique Saint Charles | Recruiting | Lyon | 69001 | France |
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| L'hôpital privé du confluent | Recruiting | Nantes | 44277 | France |
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| Hopital Bichat | Recruiting | Paris | 75018 | France |
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| Clinique des Maussins | Recruiting | Paris | 75020 | France |
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| Pavillon de la Mutualite | Recruiting | Pessac | 33608 | France |
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| Clinique Saint Michel et Sainte Anne | Recruiting | Quimper | 29000 | France |
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| Clinique Mutualiste | Recruiting | Saint-Etienne | 42000 | France |
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| Polyclinique de l'Atlantique | Recruiting | Saint-Herblain | 44819 | France |
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| C. H. St- Nazaire | Recruiting | Saint-Nazaire | 44606 | France |
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| Clinique de l'Orangerie | Recruiting | Strasbourg | 67000 | France |
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| Centre Hospitalier Princesse Grace | Recruiting | Monaco | 98000 | Monaco |
|
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D000070636 | Rotator Cuff Injuries |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D012421 | Rupture |
| D013708 | Tendon Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072228 | Arthroplasty, Replacement, Shoulder |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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