Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)

The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Arthritis of Ankle; Failure, Prosthesis

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Sandrine Angibaud; Phone Number: 352-377-1140; Email: sandrine.angibaud@exac.com
• Study Contact Backup: Name: Rachael Craig; Phone Number: 352-377-1140; Email: rachael.craig@exac.com

Study Locations

• Spain
  • Santa Cruz De Tenerife, Spain, 38320
    • Recruiting
    • Hospital Universitario de Canarias
    • Contact: Alejandro Herrera; Phone Number: + 0034 922678500
• Switzerland
  • Basel, Switzerland, CH-4010
    • Recruiting
    • SWISS ORTHO CENTER Pain Clinic Basel
    • Contact: Victor Valderrabano; Phone Number: +41 61 295 88 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Description

Inclusion Criteria:

• Patient is indicated for total ankle arthroplasty
• Patient is at least 21 years of age
• Patient is likely to be available for follow-up out to 10 years
• Patient is willing to participate by complying with pre- and postoperative visit requirements
• Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

• Patient with excessive bone loss at the ankle joint site
• Patient with severe osteoporosis
• Patient with complete talar avascular necrosis
• Patient with active osteomyelitis
• Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle
• Patient with sepsis
• Patient with vascular deficiency in the involved limb
• Pateint with neuropathic joints
• Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
• Patient with poor soft tissue coverage around the ankle
• Patient with Charcot arthropathy
• Previsous ankle arthrodesis with excision of the malleoli
• Excessive loads as cuased by activity or patient weight - per investigator discretion
• Skeletally immature patients (patient is less than 21 years if age at time of surgery)
• Patient with dementia
• Patient with known metal allergies
• Patients who are unwilling to provide informed consent
• Patients who are unlikely to be available for follow-up out to 10 years
• Patients who are not deemed suitable candidates for the subject device
• Patient is pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS	American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot	Through study completion, an average of 1 per year
SMFA	Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered	Through study completion, an average of 1 per year
SF-36	Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability	Through study completion, an average of 1 per year
Sports Frequency Score	Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete	Through study completion, an average of 1 per year
VAS Pain score and Patient Satisfaction	Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity	Through study completion, an average of 1 per year

Collaborators and Investigators

• Sponsor: Exactech
• Investigators: Principal Investigator: Victor Valderrabano, MD, PhD, SWISS ORTHO CENTER Pain Clinic Basel; Principal Investigator: Mario Herrera- Perez, MD, PhD, Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Joint Diseases; Arthritis; Prosthesis Failure
• Other Study ID Numbers: CR16-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No