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The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma.
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total hip arthroplasty (THA) and Revision THA | Other | Patients will be monitored for up to 15 years postoperatively. |
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| Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty | Other | Patients will be monitored for up to 10 years postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hip surgery with FH Ortho devices | Device | This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma. In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate (revision) of the medical device over the long term (maximum 15 years). | maximum 15 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent GAUDIOT, MD | Contact | +33 2 40 95 92 81 | vincent.gaudiot@wanadoo.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur | Recruiting | Guilherand-Granges | 07 500 | France |
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| Centre Hospitalier Du Haut Bugey | Recruiting | Oyonnax | 01 100 | France |
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| Polyclinique Reims-Courlancy | Recruiting | Reims | 51 100 | France |
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| Clinique Mutualiste La Sagesse | Recruiting | Rennes | 35 043 | France |
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| Clinique de l'Atlantique | Recruiting | Saint-Herblain | 44 800 | France |
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