INFINITY™ With ADAPTIS™ Technology Study (ITAR2)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Device: INFINITY™ with ADAPTIS™ Technology Total Ankle System

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • OrthoArizona Foot and Ankle Institute
  • California
    • Rancho Mirage, California, United States, 92270-3221
      • Eisenhower Health / Desert Orthopedic Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Orthopedic Research Center
    • Vail, Colorado, United States, 81567
      • Steadman Philippon Research Institute
  • Florida
    • Trinity, Florida, United States, 34655
      • Florida Joint Care Institute
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Slocum Research & Education Foundation
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Institute for Clinical Research
    • Germantown, Tennessee, United States, 38138
      • Campbell Clinic
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 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™ with ADAPTIS™ Technology Total Ankle System

Description

Inclusion Criteria:

• 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.

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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	10 years
Patient Satisfaction of Total Ankle Replacement (TAR)	Compare patient satisfaction of total ankle replacement (TAR) post operatively utilizing a four-point scale.	10 years

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma & Extremities

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): November 1, 2035

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 17, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: US20-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: Yes
• product manufactured in and exported from the U.S.: Yes