Active — Not RecruitingNot Applicable

UK Infinity, Post-Market Clinical Follow-up Study

United Kingdom500 participantsStarted 2016-04-29

Plain-language summary

Study Title UK Post-Market Clinical Follow-Up Of The INFINITY® Total Ankle System 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 500 with 10 sites

Who can participate

Age range21 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: Subjects to be included in the study must meet all of the following criteria: * Be 21 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 / witnessed verbal consent) Willing and able to attend the requested follow-up visits; * Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following 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

Primary Outcome Measure survivorship at 10 years

Timeframe: 10 Years

Trial details

NCT IDNCT03063593

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-12-31

View on ClinicalTrials.gov More Arthritis, Rheumatoid trials