Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up
2 other identifiers
observational
82
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2021
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
September 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 13, 2029
May 31, 2024
May 1, 2024
8 years
June 14, 2021
May 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Revision rate
Revision rate of the implant for aseptic loosening.
Up to 5 years of follow-up
Secondary Outcomes (7)
Functional outcomes evaluation such as pain and mobility
preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Functional outcomes evaluation such as mobility
preop, 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
Health status outcomes evaluation such as quality of life
preop, 1 year postop, 2 years postop, 5 years postop
- +2 more secondary outcomes
Interventions
Patients who will be implanted with a total ankle prosthesis, EasyMove.
Eligibility Criteria
Patients from participating centres will be enrolled as part of their clinical routine care.
You may qualify if:
- 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
You may not qualify if:
- Contraindications listed in the instructions for use
- Patient who is not able to express his/her non opposition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FH ORTHOlead
Study Sites (6)
Chu Brest
Brest, 29609, France
CH Raymond-Poincaré
Garches, 92380, France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925, France
Clinique Victor HUGO
Paris, 75008, France
Clinique Jouvenet
Paris, 75016, France
Centre hospitalier universitaire vaudois
Lausanne, CH-1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2021
First Posted
June 29, 2021
Study Start
September 14, 2021
Primary Completion (Estimated)
September 13, 2029
Study Completion (Estimated)
September 13, 2029
Last Updated
May 31, 2024
Record last verified: 2024-05