ClinicalTrials.gg
RecruitingNCT05691868Updated Sep 16, 2026

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

An observational study in Rheumatoid Arthritis, Arthritis of Ankle and Failure, Prosthesis, sponsored by Exactech. Recruiting at 2 sites in 2 countries. 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 2019; still recruiting 7 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
400
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 Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.

02

Conditions studied

  • Rheumatoid Arthritis
  • Arthritis of Ankle
  • Failure, Prosthesis
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's planned enrollment of 400 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid 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 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 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
  • 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
  • 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
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
400 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 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

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

07

Study locations

2 of 2 sites recruiting
  • Hospital Universitario de Canarias
    Santa Cruz de Tenerife, 38320, Spain
    Recruiting
    • Alejandro Herrera · Contact+ 0034 922678500
  • SWISS ORTHO CENTER Pain Clinic Basel
    Basel, CH-4010, Switzerland
    Recruiting
    • Victor Valderrabano · Contact+41 61 295 88 80
08

Updates

Tracking since Sep 25, 2026
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
NCT05691868
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Jan 20, 2023
Start date
Apr 8, 2019
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
Victor Valderrabano, MD, PhD
principal investigator · SWISS ORTHO CENTER Pain Clinic Basel
Mario Herrera- Perez, MD, PhD
principal investigator · Hospital Universitario de Canarias

Oversight

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

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