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

Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.

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.

Study Overview

• Status: Terminated
• Conditions: Knee Disease
• Intervention / Treatment: Device: FHK® total knee prosthesis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Laval, France, 53 000
    • Clinique du Maine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from participating hospitals will be enrolled as part of their clinical routine care

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving a prosthesis from the FHK® range	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life EQ-5D-5L score	The primary outcome measures will be determined by the EQ-5D-5L score. The EQ-5D-5L score is a self-administered quality of life questionnaire by patients. The EQ-5D-5L consists of two parts, One part with a five-dimensional system and the last one is a visual analog scale graduated from 0 to 100. We will observe the evolution of this score according to the time frame.	14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate		2 years post-op
Evolution of parameters describing pain, stability, knee mobility and patient autonomy	The secondary outcome measures will be determined by the KOOS-PS score, a patellar evaluation, and questions about physical abilities. The KOOS-PS score is a score used in the clinical evaluation of various knee pathologies.This score assesses both the long and medium term consequences of a knee injury. It contains 42 items in 5 separately scored subscales (pain, other symptoms, function in daily life, function in leisure and sports and quality of life related to the knee). The patellar evaluation is a questionnaire assessing the functional state of the knee with questions such as the level of pain in the anterior region of the knee, assessment of the strength of the quadriceps, the ability to rise from a chair. Physical abilities will be assessed with questions like the patient's walking distance, the ability to cycle, the ability to go shopping.	From the preoperative visit to 2 years postoperative.
Rate of complications		All complications will be gathered during intervention and up to 2 years postoperatively.

Collaborators and Investigators

• Sponsor: FH ORTHO

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; Knee
• Other Study ID Numbers: 2018-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No