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FH ORTHO SAS Knee Observatory
Sponsor: FH ORTHO
Summary
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 instructions for use (IFU). 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 knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery. 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 smartphone/tablet/computer) when feasible. The data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.
Official title: Post Market Clinical Follow-up of Knee Surgery Using FH ORTHO SAS Medical Devices (FH ORTHO SAS Knee Observatory)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
487
Start Date
2024-05
Completion Date
2044-06
Last Updated
2024-02-22
Healthy Volunteers
No
Conditions
Interventions
Knee surgery with FH Ortho devices
This clinical investigation is a real-life observatory designed to collect long-term clinical data on patients who have undergone knee joint replacement or knee ligament reconstruction. In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.
Locations (10)
Clinique De La Chataigneraie
Beaumont, France
Clinique De La Miotte
Belfort, France
Polyclinique St Privat
Boujan-sur-Libron, France
Clinique Du Val D'Ouest
Écully, France
C.H. Raymond Poincare
Garches, France
Hôpital Saint Vincent de Paul
Lille, France
Hôpital Prive St Grégoire
Saint-Grégoire, France
Polyclinique De L'Europe
Saint-Nazaire, France
Medipole Garonne
Toulouse, France
Hôpital Privé Océane
Vannes, France