Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device

Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Disease
• Intervention / Treatment: Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis

Detailed Description

The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• France
  • Colmar, France, 68000
    • CH Pasteur
  • Lorient, France, 56324
    • Clinique Mutualiste de la Porte de l'Orient
  • Toulouse, France, 31036
    • Médipôle Garonne

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:

• Adults subjects (≥18 years old).
• Subject implanted with FHK ASYMETRIQUE 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.

Exclusion Criteria:

• Contraindications described in the instructions for use
• Usual surgical contraindications
• Patients objecting to participate in this study
• 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 FHK ASYMETRIQUE prosthesis	Device: Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis; FHK ASYMETRIQUE 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
Safety evaluation	Survival rate	10 years post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological evaluation	Radiological results such as stability, osteointegration will be evaluated. The HKA angle will be measured. It is the angle (in degrees) between the center of the femoral head, the center of the knee and the center of the tibio-fibular mortise. This radiological evaluation is a usual assessment used in the follow-up of patients operated for a total knee replacement.	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Rate of complications	All complications will be gathered during intervention and up to 10 years postoperatively.	peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility.	Functional outcomes will be determined by the IKS score. New IKS score range from 0 to 200 with a physical score on 100 points (pain, knee's mobility, abnormal laxity, flexion deformity and Hips knee Ankle) and a functional score on 100 points (walking distance, difficulty with stairs and use of walking aids).	preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op

Collaborators and Investigators

• Sponsor: FH ORTHO

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Estimated): January 22, 2034
• Study Completion (Estimated): January 22, 2034

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; Knee
• Other Study ID Numbers: 2018-38

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