INFINITY™Total Ankle Replacement Follow-up (ITAR)

February 12, 2025 updated by: Stryker Trauma and Extremities
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design 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 150 with 9 sites

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays)

The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
    • Colorado
      • Fort Collins, Colorado, United States, 80525
        • Orthopaedic & Spine Center of the Rockies
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Illinois Bone & Joint Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Orthopaedic Associates of Michigan, PC
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital-Royal Oak
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Slocum Center for Orthopedics & Sports Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • UT Erlanger
      • Germantown, Tennessee, United States, 38138
        • Campbell Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System

Description

Inclusion Criteria:

  • Be 21 years of age or older 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™ Total Ankle System replacement prior to enrollment in the research.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survivorship at 10 Years
Time Frame: 10 years
The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic Evaluation-physician Reported Questionnaire
Time Frame: Pre-op through 2 years

Identify and assess the implant for the below:

Evidence of Subsidence Evidence Tibia and Talar Subsidence > 5° Evidence of Radiolucency Evidence Tibia and Talar Linear Radiolucency > 2mm and document if the Radiolucency is Progressive Evidence of Tibia and Talar Cystic Radiolucency > 5mm and document if the Radiolucency is Progressive Other Radiographic Findings deemed reportable by Investigator
Pre-op through 2 years
PROMIS Scale v1.2- Global Health
Time Frame: 2 years
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates andmonitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. (PROMIS Scale v1.2- Global Health) The 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. Will report change from baseline score to 2 years.
2 years
Ankle Osteoarthritis Score (AOS)
Time Frame: Pre-op though 2 years
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. Will report change from baseline score to 2 years.
Pre-op though 2 years
FAOS Questionnaire
Time Frame: 2 years
The FAOS is a self-report measure that evaluates symptoms and functional limitations in individuals with generalized foot and ankle disorders. 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). All subscales have a range from 0 (severe symptoms) to 100 (no symptoms). The total FAOS score is calculated by summing up the scores from each of the five subscales (pain, other symptoms, activities of daily living, sports and recreation, and quality of life) after individually calculating each subscale score by adding up the points from its respective questions and dividing by the maximum possible score for that subscale; the final result is then normalized to a scale from 0 (severe symptoms) to 100 (no symptoms) based on the total score across all subscales. We report change from baseline score to 2 years.
2 years
TAR Satisfaction Questionnaire
Time Frame: Pre-op through 2 years
Compare satisfaction of total ankle replacement post operatively utilizing a four point scale
Pre-op through 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Trauma and Extremities

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rebecca Gibson, Stryker Trauma and Extremities

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US17-TAR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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