Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®

FH ORTHO

Status: Active, not recruiting

Conditions: Ankle Injuries and Disorders

Treatments: Device: Total Ankle Prosthesis, EasyMove®

Study type: Observational

Funder types: Industry

Identifiers

NCT04944576

2018-42

2020-A03401-38 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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