INFINITY™Total Ankle Replacement Follow-up

Stryker Trauma and Extremities155 enrolled

Overview

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

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

155

Conditions

Arthritis, Rheumatoid

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (9)

Eisenhower Medical Center

Rancho Mirage, California, United States

Orthopaedic & Spine Center of the Rockies

Fort Collins, Colorado, United States

Illinois Bone & Joint Institute

Libertyville, Illinois, United States

Outcomes

Primary Outcomes

Survivorship at 10 Years

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

Time frame: 10 years

Secondary Outcomes

Radiographic Evaluation-physician Reported Questionnaire

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

Time frame: Pre-op through 2 years

PROMIS Scale v1.2- Global Health

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.

Time frame: 2 years

Ankle Osteoarthritis Score (AOS)

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.

Data from ClinicalTrials.gov

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FAOS Questionnaire

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.

Time frame: 2 years