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

Ankle Injuries and Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04944576
• Other study ID #: 2018-42
• Secondary ID: 2020-A03401-38
• Status: Active, not recruiting
• Start date: September 14, 2021
• Est. completion date: September 13, 2029

Study information

• Verified date: May 2024
• Source: FH ORTHO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: September 13, 2029
• Est. primary completion date: September 13, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injuries and Disorders

Intervention

Device:
• Total Ankle Prosthesis, EasyMove®
Patients who will be implanted with a total ankle prosthesis, EasyMove.

Locations

Country	Name	City	State
France	Chu Brest	Brest
France	CH Raymond-Poincaré	Garches
France	Centre Hospitalier Départemental Vendée	La Roche-sur-yon
France	Clinique Jouvenet	Paris
France	Clinique Victor HUGO	Paris
Switzerland	Centre hospitalier universitaire vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
FH ORTHO

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision rate	Revision rate of the implant for aseptic loosening.	Up to 5 years of follow-up
Secondary	Functional outcomes evaluation such as pain and mobility	Functional ouctomes will be evaluated through the AOFAS score. This score is comprised of nine questions covering three categories: pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. The higher the score, the better the patient outcome. AOFAS is a clinician reporting tool that required both patient and provider participation to be fully complete. The AOFAS score will be compared to its MCID at each follow-up visit. The MCID will be calculated based on the distribution-based MCID method.	preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Secondary	Functional outcomes evaluation such as mobility	Functional ouctomes will be evaluated through the FAAM score. This score is a 29-item questionnaire divided into two subscales: 21-item Activities of Daily Living Subscale and 8-item Sports Subscale. Item score totals, which range from 0 to 84 for the Activities of Daily Living subscale and 0 to 32 for the Sports subscale, are transformed to percentage scores. The higher the score, the better the patient outcomes. It is a self-report outcome instrument. The FAAM score will be compared to its MCID at each follow-up visit. The Minimal Clinically Important Difference (MCID) of the Foot and Ankle Ability Measure (FAAM) at 1 year of follow-up compared to the theorical MCID retrieved in the literature (MCID = 31.2 (sd=25.3, superiority comparison)). For the following follow-up, the MCID will be calculated based on the distribution-based MCID method.	preop, 1 year postop, 2 years postop, 5 years postop
Secondary	Functional outcomes evaluation such as mobility	Functional ouctomes will be evaluated through clinical data such as the range of motion.	preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Secondary	Health status outcomes evaluation such as pain	Health status outcomes will be evaluated through a visual analogue scale to measure pain.	preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Secondary	Health status outcomes evaluation such as quality of life	Health status outcomes will be evaluated through the SF-12 questionnaire to measure the quality of life. It is a self-reported outcome measure, composed of 12 questions. It provides an eight-scale profile of functional health and wellbeing, as well as two psychometrically based physical and mental health summary measures, scored on a T-score metric. The higher the score, the better the patient outcomes. The SF-12 score will be compared to its MCID at each follow-up visit. The MCID will be calculated based on the distribution-based MCID method.	preop, 1 year postop, 2 years postop, 5 years postop
Secondary	Radiological data evaluation	Radiological data results such as the postion of the implant, lucency, calcification will be evaluated.	preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Secondary	Rate of complications	All complications will be gathered from the intervention up to 5 years of follow-up.	perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop