INFINITY™Total Ankle Replacement Follow-up (ITAR)

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: Terminated
• Conditions: Arthritis, Rheumatoid

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: Observational
• Enrollment (Actual): 148

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of the INFINITY™ Total Ankle System at 10 years	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.	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 osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.	Pre-op through 10 years
PROMIS® Global Health	Compare the improvements in self-reported physical, mental, and social health measures from pre-op through 10 years post operatively; assessed by PROMIS® Global Health.	Pre-op through 10 years
Ankle Osteoarthritis Score (AOS)	Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.	Pre-op through 10 years
FAOS questionnaire	Compare the improvement in patient/physician reported function scores from pre-op through 10 years post-operatively, assessed by the FAOS questionnaire.	Pre-op through 10 years
TAR satisfaction questionnaire	Compare satisfaction of total ankle replacement post operatively utilizing a four point scale	Pre-op through 10 years

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID 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