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FH ORTHO SAS Knee Observatory

NCT06207968 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 487

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Knee Surgery

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.

Sponsors & Collaborators

  • FH ORTHO

    lead INDUSTRY

Principal Investigators

  • Charles KAJETANEK, MD · Hôpitaux Privés Rennais - Saint-Grégoire (Vivalto Santé) Institut Locomoteur de l'Ouest

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2044-06-30
Completion
2044-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06207968 on ClinicalTrials.gov