UK Infinity, Post-Market Clinical Follow-up Study
UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System
1 other identifier
observational
500
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
January 20, 2026
January 1, 2026
13.7 years
February 15, 2017
January 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure survivorship at 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.
10 Years
Secondary Outcomes (4)
EQ5D-EuroQol-questionnaire
From pre-op through 10 years
Ankle Osteoarthritis Score (AOS)-questionnaire
From Pre-op through 10 years
Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire
From Pre-op through 10 years
Radiographic evaluation-physician reported questionnaire
From Pre-op through 10 years
Eligibility Criteria
Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Torbay Hospital
Torquay, Devon, TQ2 7AA, United Kingdom
Royal Bournemouth Hosptial
Bournemouth, Dorset, BH7 7DW, United Kingdom
University Hairmyres Hospital
Bothwell, Scotland, G71 8BB, United Kingdom
RJAH Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG, United Kingdom
Sheffield Teaching Hospital
Sheffield, South Yorksire, S5 7AU, United Kingdom
North Bristol NHS Trust Southmead Hospital
Bristol, BS105NB, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
Royal National Orthopaedic Hospital
Middlesex, HA7 4LP, United Kingdom
North Tyneside General Hospital
Newcastle upon Tyne, NE29 8NH, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Wrightington Hospital
Wigan, WN6 9EP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Townshend, MD
Northumbria Trust
- STUDY DIRECTOR
Rebecca Gibson
Stryker Trauma & Extremeties
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 24, 2017
Study Start
April 29, 2016
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share