Clinical trial NCT04594993: INFINITY™ With ADAPTIS™ Technology Study
Official title: INFINITY™ With ADAPTIS™ Technology Total Ankle Replacement Follow-Up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis, Rheumatoid
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ with ADAPTIS™ Technology Total Ankle System

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic Evaluation- Physician Reported Questionnaire
timeFrame: 10 years
measure: PROMIS® Global Health Questionnaire
timeFrame: 10 years
measure: Ankle Osteoarthritis Score (AOS) Questionnaire
timeFrame: 10 years
measure: Foot & Ankle Observational Score (FAOS) questionnaire.
timeFrame: 10 years
measure: Patient Satisfaction of Total Ankle Replacement (TAR)
timeFrame: 10 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: OrthoArizona Foot and Ankle Institute
state: Arizona
city: Rancho Mirage
country: United States
facility: Eisenhower Health / Desert Orthopedic Center
state: California
city: Aurora
country: United States
facility: University of Colorado Orthopedic Research Center
state: Colorado
city: Vail
country: United States
facility: Steadman Philippon Research Institute
state: Colorado
city: Trinity
country: United States
facility: Florida Joint Care Institute
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Eugene
country: United States
facility: Slocum Center for Orthopedics & Sports Medicine
state: Oregon
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Institute for Clinical Research
state: Tennessee
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Stryker Trauma & Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: