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This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.
In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.
This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).
It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.
This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FH ORTHO shoulder patients | Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARROW | Device | Patients included in the study are patients operated with one or more shoulder medical device fabricated by FH ORTHO. Medical devices of interest are CE marked and include ARROW and ARROW prosthesis, Telegraph Evolution humeral nail and STRAPFLEX strapping system. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the medical devices over long term follow-up (maximum10 years) | Functional performance measured by the Constant-Murley score | maximum 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| revision rate medical devices over long term follow-up (maximum10 years) | maximum 10 years |
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Inclusion criteria:
Exclusion criteria:
1. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation
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Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cédric FERRY | Contact | +33 (0)6 49 63 78 29 | c.ferry@fhortho.com | |
| Stéphanie LHUILLIER | Contact | +33 (0)6 07 34 59 65 | s.lhuillier@fhortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique VIA DOMITIA | Recruiting | Lunel | 34400 | France |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
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| Clinique Bizet | Recruiting | Paris | 75116 | France |
|
| Clinique de l'Union | Recruiting | Saint-Jean | 31243 | France |
|