UK Infinity, Post-Market Clinical Follow-up Study

UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System

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

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis, Rheumatoid; Post-traumatic Osteoarthritis; Degenerative Arthritis

Detailed Description

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 N Subjects 500 with 10 sites Follow-Up Schedule Subject enrollment will consist of a Pre-operative, Operative, 6 months, 1 yr., 2 yr., 5yr., 7 yr., 10 yr., and an unscheduled visit as needed.

Primary Objective Evaluate the long-term survivorship of the INFINITY® implant over 10 years

Secondary Objective(s) Secondary objectives assessed will be to:

• Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.
• Compare the improvements in self-reported pain and social interaction for quality of life measures from pre-op through 10 years post operatively; assessed by EuroQol (EQ5D5L).
• Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.
• Compare the improvement in self-reported pain-free function scores from pre-op through 10 years post-operatively, assessed by the Manchester Oxford Foot Questionnaire (MOXFQ) walking/standing scores.
• Identify and report the safety of the implant in terms of complications and adverse events.

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS105NB
    • North Bristol NHS Trust Southmead Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter NHS Foundation Trust
  • Middlesex, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital
  • Newcastle upon Tyne, United Kingdom, NE29 8NH
    • North Tyneside General Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust
  • Wigan, United Kingdom, WN6 9EP
    • Wrightington Hospital
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Torbay Hospital
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • Royal Bournemouth Hosptial
  • Scotland
    • Bothwell, Scotland, United Kingdom, G71 8BB
      • University Hairmyres Hospital
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • RJAH Orthopaedic Hospital
  • South Yorksire
    • Sheffield, South Yorksire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-EuroQol-questionnaire	Compare the improvement in self-reported pain and social interaction for quality of life measures	From pre-op through 10 years
Ankle Osteoarthritis Score (AOS)-questionnaire	Self-reported to compare pain and functional improvement, which is a visual analogue scale specifically designed as a modification of the Foot function Index	From Pre-op through 10 years
Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire	Compare the improvement in self-reported pain-free function scores (walking/standing scores)	From Pre-op through 10 years
Radiographic evaluation-physician reported questionnaire	identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation	From Pre-op through 10 years

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Chair: David Townshend, MD, Northumbria Trust; Study Director: Rebecca Gibson, Stryker Trauma & Extremeties

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2016
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Osteoarthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: UK15-TAR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No