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

Knee Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04578951
• Other study ID #: 2018-41
• Status: Terminated
• Start date: September 28, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: FH ORTHO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Disease

Intervention

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.

Locations

Country	Name	City	State
France	Clinique du Maine	Laval

Sponsors (1)

Lead Sponsor	Collaborator
FH ORTHO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival rate		2 years post-op
Secondary	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.
Secondary	Rate of complications		All complications will be gathered during intervention and up to 2 years postoperatively.