INFINITY™ With ADAPTIS™ Technology Study

N/AActive Not RecruitingNCT04594993

Stryker Trauma and Extremities200 enrolled

Overview

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

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

200

Conditions

Arthritis, Rheumatoid

Interventions

INFINITY™ with ADAPTIS™ Technology Total Ankle SystemDEVICE

Total Ankle Replacement

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (13)

OrthoArizona Foot and Ankle Institute

Gilbert, Arizona, United States

Eisenhower Health / Desert Orthopedic Center

Rancho Mirage, California, United States

University of Colorado Orthopedic Research Center

Outcomes

Primary Outcomes

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.

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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