ClinicalTrials.gg
RecruitingNCT05619588Updated Sep 16, 2026

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

An observational study in Ankle Rheumatoid Arthritis, Arthritis of Ankle and Failure, Prosthesis, sponsored by Exactech. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Exactech · Observational

From the registry’s dates

  • Started Apr 2017; still recruiting 9 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
370
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ankle Rheumatoid Arthritis
  • Arthritis of Ankle
  • Failure, Prosthesis

Browse trials for

03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 370 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Exactech is the lead sponsor of 17 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
370 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

07

Study locations

2 of 2 sites recruiting
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Recruiting
  • Duke Department of Orthopaedic Surgery
    Durham, North Carolina 27703, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2017 (actual). Primary completion is estimated for Dec 2030, 164 months after the start.

Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 164 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2022
First posted
Nov 17, 2022
StartActual
Apr 4, 2017
Primary completionEst.
Dec 31, 2030
CompletionEst.
Sep 30, 2031
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05619588
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Apr 4, 2017
Primary completion
Dec 31, 2030 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
Sep 16, 2026

Study contacts

Rachael Craig
Contact
rachael.craig@advita.com
1-833-423-8482
Sandrine Angibaud
Contact
sandrine.angibaud@advita.com
1-833-423-8482
Samuel Adams, MD
principal investigator · Duke Department of Orthopaedic Surgery
Edward Haupt, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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