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NCT Number: NCT05619588

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

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.

Recruiting

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Key information

Conditions

Ankle Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. AOFAS

    Time frame: Through study completion, an average of 1 per year

    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

  2. SMFA

    Time frame: Through study completion, an average of 1 per year

    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

  3. SF-36

    Time frame: Through study completion, an average of 1 per year

    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

  4. Sports Frequency Score

    Time frame: Through study completion, an average of 1 per year

    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

  5. VAS Pain and Patient Satisfaction Score

    Time frame: Through study completion, an average of 1 per year

    Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity

Study contacts

Contact information is provided by the study sponsor or research team.

Rachael Craig

CONTACT

[email protected]

352-377-1140

Sandrine Angibaud

CONTACT

[email protected]

352-377-1140

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2030
Study completion
2031
First posted
Nov 17, 2022
Registry last updated
Feb 27, 2025

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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