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Clinical Trials in the UK / NCT03063593
Active, not recruiting Observational

UK Infinity, Post-Market Clinical Follow-up Study

NCT03063593 · tracked via the Priya Life Science UK tracker
Sponsor
Stryker Trauma and Extremities
Phase
Observational
Started
2016-04-29
Last updated
2026-08-28

Condition(s) studied

Arthritis, RheumatoidPost-traumatic OsteoarthritisDegenerative Arthritis

Study 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

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Primary Outcome Measure survivorship at 10 years — 10 Years
    The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY® Total Ankle System performance/survivorship at up to 10 years.

Trial sites (12)

FacilityCityRegionStatus
Torbay Hospital Torquay Devon
Royal Bournemouth Hosptial Bournemouth Dorset
University Hairmyres Hospital Bothwell Scotland
RJAH Orthopaedic Hospital Oswestry Shropshire
Sheffield Teaching Hospital Sheffield South Yorksire
Nottingham University Hospitals NHS Trust Nottingham United Kingdom
North Bristol NHS Trust Southmead Hospital Bristol United Kingdom
Royal Infirmary of Edinburgh Edinburgh United Kingdom
Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom
Royal National Orthopaedic Hospital Middlesex United Kingdom
North Tyneside General Hospital Newcastle upon Tyne United Kingdom
Wrightington Hospital Wigan United Kingdom

More Stryker Trauma and Extremities trials in the UK

Perform Humeral System Study Recruiting

Other trials for the same condition

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) Active, not recruiting
Anatomical Shoulder Domelock System Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03063593 on ClinicalTrials.gov ↗ ← All trials in the UK