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

NCT04578951 | Terminated

• 1 other identifier: 2018-41
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Disease

Keywords

Knee; Arthroplasty; Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Survival rate

  2 years post-op

• Evolution of parameters describing pain, stability, knee mobility and patient autonomy

  From the preoperative visit to 2 years postoperative.

• Rate of complications

  All complications will be gathered during intervention and up to 2 years postoperatively.

Study Arms (1)

Patients receiving a prosthesis from the FHK® range

Device: FHK® total knee prosthesis

Interventions

FHK® total knee prosthesis DEVICE

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

Patients receiving a prosthesis from the FHK® range

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• FH ORTHO: lead

Study Sites (1)

Clinique du Maine

Laval, 53 000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: September 28, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)