Active — Not RecruitingNot Applicable

INFINITY™ With ADAPTIS™ Technology Study

United States200 participantsStarted 2021-02-09

Plain-language 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

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Measure survivorship of INFINITY™ with ADAPTIS™ Technology Total Ankle System at 10 years

Timeframe: 10 years

Trial details

NCT IDNCT04594993

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2033-11

View on ClinicalTrials.gov More Arthritis, Rheumatoid trials