Ankle Rheumatoid ArthritisNCT05619588
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
An observational study of Ankle Rheumatoid Arthritis and Arthritis of Ankle, run by Exactech at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ankle Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis
- How many people
- 370 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2017to 30 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke Department of Orthopaedic Surgery
Durham, North Carolina, 27703
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: 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.
- Medical subject headings
- Prosthesis Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start4 Apr 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by ExactechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Adams, MD, Principal investigator, Duke Department of Orthopaedic SurgeryEdward Haupt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619588
- Sponsor's protocol ID
- CR16-002
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System
- ClinicalTrials.gov ID
- NCT05619588
- Acronym / sponsor ID
- CR16-002
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Adams, MD principal investigator
Duke Department of Orthopaedic Surgery
Edward Haupt, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Rheumatoid Arthritis and Arthritis of Ankle, run by Exactech at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachael Craig (1-833-423-8482, rachael.craig@advita.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS (time frame: Through study completion, an average of 1 per year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.