Clinical trial NCT03277989: INFINITY™Total Ankle Replacement Follow-up
Official title: INFINITY™Total Ankle Replacement Follow-up
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 155
Sex: ALL
Minimum age (years): 21
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™ Total Ankle System

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship at 10 Years
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic Evaluation-physician Reported Questionnaire
timeFrame: Pre-op through 2 years
measure: PROMIS Scale v1.2- Global Health
timeFrame: 2 years
measure: Ankle Osteoarthritis Score (AOS)
timeFrame: Pre-op though 2 years
measure: FAOS Questionnaire
timeFrame: 2 years
measure: TAR Satisfaction Questionnaire
timeFrame: Pre-op through 2 years
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Fort Collins
country: United States
facility: Orthopaedic & Spine Center of the Rockies
state: Colorado
city: Libertyville
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, PC
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital-Royal Oak
state: Michigan
city: Eugene
country: United States
facility: Slocum Center for Orthopedics & Sports Medicine
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: UT Erlanger
state: Tennessee
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: