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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-14

Study Completion Date

2029-09-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ankle Injuries and Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Total Ankle Prosthesis, EasyMove®

Patients who will be implanted with a total ankle prosthesis, EasyMove.

Intervention Type DEVICE

Eligibility Criteria

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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