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NOT YET RECRUITING
NCT06207968

FH ORTHO SAS Knee Observatory

Sponsor: FH ORTHO

View on ClinicalTrials.gov

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

DEVICE

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