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

• Sponsor: FH ORTHO (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04944576
• Collaborator: (none)
• Enrollment: 82
• Locations: 4
• Anticipated Duration (Months): 84
• Patients Per Site: 20.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Injuries and Disorders	Device: Total Ankle Prosthesis, EasyMove®

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 82 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up
• Actual Study Start Date: Sep 14, 2021
• Anticipated Primary Completion Date: Sep 13, 2028
• Anticipated Study Completion Date: Sep 13, 2028

Outcome Measures

Primary Outcome Measures

1. Revision rate [Up to 5 years of follow-up]

   Revision rate of the implant for aseptic loosening.

Secondary Outcome Measures

1. Functional outcomes evaluation such as pain and mobility [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.

2. Functional outcomes evaluation such as mobility [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.

3. Functional outcomes evaluation such as mobility [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 [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 [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.

6. Radiological data evaluation [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Raymond-Poincaré	Garches		France	92380
2	Centre Hospitalier Départemental Vendée	La Roche-sur-yon		France	85925
3	Clinique Victor HUGO	Paris		France	75008
4	Centre hospitalier universitaire vaudois	Lausanne		Switzerland	CH-1011

Sponsors and Collaborators

• FH ORTHO

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FH ORTHO
• ClinicalTrials.gov Identifier: NCT04944576
• Other Study ID Numbers: 2018-42; 2020-A03401-38
• First Posted: Jun 29, 2021
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ankle Injuries

Study Results

No Results Posted as of Aug 11, 2022