Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up

FH ORTHO6 sites in 2 countries82 target enrollmentSeptember 14, 2021

ConditionsAnkle Injuries and Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ankle Injuries and Disorders
Sponsor: FH ORTHO
Enrollment: 82
Locations: 6
Primary Endpoint: Revision rate
Status: Active, Not Recruiting
Last Updated: last year

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 safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

Detailed Description

The primary objective is to evaluate the safety of the total ankle prosthesis, EasyMove, up to five years of follow-up. The secondary objectives are to evaluate both the safety and the performance of the total ankle prosthesis, EasyMove, up to five years of follow-up.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

September 13, 2029

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

FH ORTHO

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient implanted with the studied device according to the instructions for use, for primary surgery in patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis
•Adult patient (≥18 years old)
•Patient who received an information form and is willing to participate in the study

Exclusion Criteria

•Contraindications listed in the instructions for use
•Patient who is not able to express his/her non opposition

Outcomes

Primary Outcomes

Revision rate

Time Frame: Up to 5 years of follow-up

Revision rate of the implant for aseptic loosening.

Secondary Outcomes

Radiological data evaluation(preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop)
Functional outcomes evaluation such as pain and mobility(preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop)
Health status outcomes evaluation such as quality of life(preop, 1 year postop, 2 years postop, 5 years postop)
Rate of complications(perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop)
Functional outcomes evaluation such as mobility(preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop)
Health status outcomes evaluation such as pain(preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop)