Clinical trial NCT04944576: Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
Official title: Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ankle Injuries and Disorders
Lead sponsor: FH ORTHO
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from participating centres will be enrolled as part of their clinical routine care.

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.

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

Primary outcomes:
measure: Revision rate
timeFrame: Up to 5 years of follow-up
Secondary outcomes:
measure: Functional outcomes evaluation such as pain and mobility
timeFrame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
measure: Functional outcomes evaluation such as mobility
timeFrame: preop, 1 year postop, 2 years postop, 5 years postop
measure: Functional outcomes evaluation such as mobility
timeFrame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
measure: Health status outcomes evaluation such as pain
timeFrame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
measure: Health status outcomes evaluation such as quality of life
timeFrame: preop, 1 year postop, 2 years postop, 5 years postop
measure: Radiological data evaluation
timeFrame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
measure: Rate of complications
timeFrame: perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
city: Garches
country: France
facility: CH Raymond-Poincaré
city: La Roche-sur-yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Paris
country: France
facility: Clinique Victor HUGO
city: Paris
country: France
facility: Clinique Jouvenet
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois
Study officials:
References: