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

FH ORTHO3 sites in 1 country43 target enrollmentJanuary 22, 2020

ConditionsKnee Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Disease
Sponsor: FH ORTHO
Enrollment: 43
Locations: 3
Primary Endpoint: Safety evaluation
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

January 22, 2020

End Date

January 22, 2034

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

FH ORTHO

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety evaluation

Time Frame: 10 years post-op

Survival rate

Secondary Outcomes

Radiological evaluation(preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op)
Rate of complications(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.(preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op)