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NCT Number: NCT04944576

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ankle Injuries and Disorders Ankle Injuries Disease Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Ankle Prosthesis, EasyMove®

Device

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

Primary outcomes

  1. Revision rate

    Time frame: Up to 5 years of follow-up

    Revision rate of the implant for aseptic loosening.

Secondary outcomes

  1. Functional outcomes evaluation such as pain and mobility

    Time frame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop

    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.

  2. Functional outcomes evaluation such as mobility

    Time frame: preop, 1 year postop, 2 years postop, 5 years postop

    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.

  3. Functional outcomes evaluation such as mobility

    Time frame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop

    Functional ouctomes will be evaluated through clinical data such as the range of motion.

  4. Health status outcomes evaluation such as pain

    Time frame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop

    Health status outcomes will be evaluated through a visual analogue scale to measure pain.

  5. Health status outcomes evaluation such as quality of life

    Time frame: preop, 1 year postop, 2 years postop, 5 years postop

    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.

  6. Radiological data evaluation

    Time frame: preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop

    Radiological data results such as the postion of the implant, lucency, calcification will be evaluated.

  7. Rate of complications

    Time frame: perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop

    All complications will be gathered from the intervention up to 5 years of follow-up.

Sponsors and collaborators

Lead sponsor

FH ORTHO

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jun 29, 2021
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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