INFINITY™Total Ankle Replacement Follow-up

NCT03277989 | Terminated Results

• 1 other identifier: US17-TAR-001
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Survivorship at 10 Years

  The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis.

  10 years

Secondary Outcomes (5)

• Radiographic Evaluation-physician Reported Questionnaire

  Pre-op through 2 years

• PROMIS Scale v1.2- Global Health

  2 years

• Ankle Osteoarthritis Score (AOS)

  Pre-op though 2 years

• FAOS Questionnaire

  2 years

• TAR Satisfaction Questionnaire

  Pre-op through 2 years

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (9)

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Orthopaedic & Spine Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Illinois Bone & Joint Institute

Libertyville, Illinois, 60048, United States

Location

Orthopaedic Associates of Michigan, PC

Grand Rapids, Michigan, 49525, United States

Location

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, 97401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UT Erlanger

Chattanooga, Tennessee, 37403, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.

Results Point of Contact

• Title: Jennifer Seidman, Manager, Clinical Research
• Organization: Stryker

jennifer.seidman@stryker.com

9016338616

Study Officials

• Rebecca Gibson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: October 9, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)