Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 370

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

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Recruiting
      • Duke University Medical Center
      • Contact: Amanda Roberston; Phone Number: 919-584-9493

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 skeletally mature
• Patient is mentally capable of completing follow-up forms
• Patient will be available for follow-up out to 10 years
• Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator
• 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
• Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
• Patient 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
• Previous ankle arthrodesis with excision of the malleoli
• Excessive loads as caused 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
• Patient who 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 and Patient Satisfaction Score	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

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Joint Diseases; Musculoskeletal Diseases; Arthritis; Prosthesis Failure
• Other Study ID Numbers: CR16-002

Drug and device information, study documents

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