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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00760-51 | Other Identifier | ANSM |
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This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception.
Recruitment will include all cases available at the selected investigation centers.
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: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Trauma Indications | Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for traumatic indications |
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| Group 2: Long Cemented HUMELOCK II® Hemi Anatomic Shoulder System for Revision Indications | Subjects treated with cemented long HUMELOCK II® Hemi Anatomic Shoulder System for revision indications |
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| Group 3: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Trauma Indications | Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for traumatic indications |
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| Group 4: Long Cemented HUMELOCK II® Reversible Total Shoulder System for Revision Indications | Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder arthroplasty | Procedure | Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate (KM) at 10 years postoperative | Survival rate (%) at 10 years calculated by means of Kaplan-Meier method | at the end of the postoperative follow-up period of 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate (KM) at each postoperative visit | Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method | 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 |
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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 | +33 6 09 25 38 08 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d' Angers | Angers | 49933 | France |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D000072228 | Arthroplasty, Replacement, Shoulder |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 postopererative visit | The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function and the lower the pain is. | 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 | ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function. | 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 | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | 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) |
| Hôpital privé Saint-Martin | Caen | 14000 | France |
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| Clinique Drouot Laffitte | Paris | 75009 | France |
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| Hôpital Nord | Saint-Priest-en-Jarez | 42277 | France |
|
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |