NCT04594993

Brief 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 to 13 sites

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
115mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2021Nov 2035

First Submitted

Initial submission to the registry

October 7, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 9, 2021

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2033

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2035

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

12.7 years

First QC Date

October 7, 2020

Last Update Submit

March 20, 2026

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Radiographic Evaluation- Physician Reported Questionnaire

    10 years

  • PROMIS® Global Health Questionnaire

    10 years

  • Ankle Osteoarthritis Score (AOS) Questionnaire

    10 years

  • Foot & Ankle Observational Score (FAOS) questionnaire.

    10 years

  • Patient Satisfaction of Total Ankle Replacement (TAR)

    10 years

Interventions

INFINITY™ with ADAPTIS™ Technology Total Ankle SystemDEVICE

Total Ankle Replacement

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

OrthoArizona Foot and Ankle Institute

Gilbert, Arizona, 85234, United States

Location

Eisenhower Health / Desert Orthopedic Center

Rancho Mirage, California, 92270-3221, United States

Location

University of Colorado Orthopedic Research Center

Aurora, Colorado, 80045, United States

Location

Steadman Philippon Research Institute

Vail, Colorado, 81567, United States

Location

Florida Joint Care Institute

Trinity, Florida, 34655, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

Location

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Erlanger Institute for Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rebecca Gibson

    Stryker Trauma & Extremities

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 20, 2020

Study Start

February 9, 2021

Primary Completion (Estimated)

November 1, 2033

Study Completion (Estimated)

November 1, 2035

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(13)