Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.

NCT ID: NCT04578951

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-28

Study Completion Date

2023-03-30

Brief Summary

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As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.

This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

Detailed Description

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The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.

The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.

Conditions

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Knee Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving a prosthesis from the FHK® range

FHK® total knee prosthesis

Intervention Type DEVICE

FHK® prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.

Interventions

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FHK® total knee prosthesis

FHK® prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject implanted with FHK® prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
* Subject who received an information form and is willing to participate in the study.
* Adults subjects (≥18 years old).
* Access to an internet connection allowing to complete the questionnaires on the online platform

Exclusion Criteria

* Contraindications described in the instructions for use
* Subject who is not able to express his/her non-opposition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FH ORTHO

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique du Maine

Laval, , France

Site Status

Countries

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France

Other Identifiers

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2018-41

Identifier Type: -

Identifier Source: org_study_id

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