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NCT05619588Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
370 (estimated)
First submitted
9 Nov 2022
Start date
4 Apr 2017
Primary completion date
31 Dec 2030
Lead sponsor
Exactech
NCT number
NCT05619588

What you commit to

  • Study type: Observational
  • Planned participants: 370
  • From 4 Apr 2017 to the primary completion date, 31 Dec 2030
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
  • Previous ankle arthrodesis with excision of the malleoli

Other illness

  • Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle
  • 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 dementia
  • Patient with known metal allergies

Age

  • Skeletally immature patients (patient is less than 21 years if age at time of surgery)

Other

  • 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 Sepsis
  • Patient with Vascular deficiency in the involved limb
  • Patient with Neuropathic joints
  • Patient with Poor soft tissue coverage around the ankle
  • Patient with Charcot arthropathy
  • Excessive loads as caused by activity or patient weight - per investigator discretion
  • Patient who is pregnant

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke Department of Orthopaedic Surgery
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.