Arthritis, RheumatoidITAR2NCT04594993
INFINITY™ With ADAPTIS™ Technology Study
An observational study of Arthritis, Rheumatoid, run by Stryker Trauma and Extremities at 13 sites in United States.
Trial summary
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- INFINITY™ with ADAPTIS™ Technology Total Ankle System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 13 sitesUnited States
- Study dates
- 9 Feb 2021to Nov 2035
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ with ADAPTIS™ Technology Total Ankle System
Who may be able to join
- Be over 22 years of age at the time of surgery;
- Diagnosed with unilateral and/or bilateral ankle joint disease;
- Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;
- Willing and able to consent to participate (written, informed consent;
- Willing and able to attend the requested follow-up visits;
- A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment.
Who cannot join
- Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
- Subjects requiring revision total ankle replacement of the ankle being considered for study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Colorado Orthopedic Research Center
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Erlanger Institute for Clinical Research
Chattanooga, Tennessee, 37403
Slocum Research & Education Foundation
Eugene, Oregon, 97401
Campbell Clinic
Germantown, Tennessee, 38138
OrthoArizona Foot and Ankle Institute
Gilbert, Arizona, 85234
Loyola University Medical Center
Maywood, Illinois, 60153
Southern Oregon Orthopedics
Medford, Oregon, 97504
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Hospital for Special Surgery
New York, New York, 10021
Eisenhower Health / Desert Orthopedic Center
Rancho Mirage, California, 92270-3221
Florida Joint Care Institute
Trinity, Florida, 34655
Steadman Philippon Research Institute
Vail, Colorado, 81567
About this study
Official title: INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites
Read the detailed description
The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- INFINITY™ with ADAPTIS™ Technology Total Ankle System
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFINITY™ with ADAPTIS™ Technology Total Ankle SystemDevice
Total Ankle Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years
Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.
Measured: 10 years
Secondary outcomes (5)
Radiographic Evaluation- Physician Reported Questionnaire
Identify and assess the implant for component loosening and/or subsidence, any radiolucency and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.
Measured: 10 years
PROMIS® Global Health Questionnaire
Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global HealthThe PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "TScore" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: 10 years
Ankle Osteoarthritis Score (AOS) Questionnaire
Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS). AOS is a reliable, validated, visual analog-based,AOS is a reliable, validated, visual analog-based, disease-specific self-administered instrument designed specifically to measure disability and pain from ankle osteoarthritis. Both Pain and Disability components are used to calculate the total score. The score is from zero to one hundred with a lower score indicating more normal function. A minimal clinically important difference (MCID) for the Total AOS score reduction from baseline has been established: 12.35 points.
Measured: 10 years
Foot & Ankle Observational Score (FAOS) questionnaire.
Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the Foot \& Ankle Observational Score (FAOS) questionnaire. The FAOS is a self-report measure that evaluates symptoms and functional limitations in individuals with generalized foot and ankle disorders. Items for the FAOS were adapted from the Knee Injury and Osteoarthritis Outcome Score. The FAOS is composed of the following 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (7 items), sports and recreational activities (5 items), and foot and ankle-related quality of life (4 items). Each subscale has a potential range from 0 to 100. Where 100 indicates no problems and 0 indicates extreme problems.
Measured: 10 years
Patient Satisfaction of Total Ankle Replacement (TAR)
Compare patient satisfaction of total ankle replacement (TAR) post operatively utilizing a four-point scale.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start9 Feb 2021
- Primary completionNov 2033 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594993
- Sponsor's protocol ID
- US20-TAR-001
- Acronym
- ITAR2
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2020
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
- ClinicalTrials.gov ID
- NCT04594993
- Acronym / sponsor ID
- ITAR2 / US20-TAR-001
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Nov 2033 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 20 Oct 2020 (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.
INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites
Detailed description
The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ with ADAPTIS™ Technology Total Ankle System
Key inclusion criteria (6 listed)
- Be over 22 years of age at the time of surgery;
- Diagnosed with unilateral and/or bilateral ankle joint disease;
- Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;
- Willing and able to consent to participate (written, informed consent;
- Willing and able to attend the requested follow-up visits;
Key exclusion criteria (2 listed)
- Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
- Subjects requiring revision total ankle replacement of the ankle being considered for study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFINITY™ with ADAPTIS™ Technology Total Ankle SystemTotal Ankle Replacement | Device | – |
Primary outcome
Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years
Time frame: 10 years
Assess the 10-year survivorship of 200 patients implanted with the INFINITY™ with ADAPTIS™ Technology Total Ankle System is non-inferior to other, similar devices.
5 secondary outcomes
Radiographic Evaluation- Physician Reported Questionnaire
Time frame: 10 years
PROMIS® Global Health Questionnaire
Time frame: 10 years
Ankle Osteoarthritis Score (AOS) Questionnaire
Time frame: 10 years
Foot & Ankle Observational Score (FAOS) questionnaire.
Time frame: 10 years
Patient Satisfaction of Total Ankle Replacement (TAR)
Time frame: 10 years
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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma & Extremities
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Stryker Trauma and Extremities at 13 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 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years (time frame: 10 years). 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 25 Aug 2026.