UK Infinity, Post-Market Clinical Follow-up Study

NCT ID: NCT03063593

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-29
• Study Completion Date: 2029-12-31

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

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

Conditions

Arthritis, Rheumatoid; Post-traumatic Osteoarthritis; Degenerative Arthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Townshend, MD

Role: STUDY_CHAIR

Northumbria Trust

Rebecca Gibson

Role: STUDY_DIRECTOR

Stryker Trauma & Extremeties

Locations

Torbay Hospital

Torquay, Devon, United Kingdom

Royal Bournemouth Hosptial

Bournemouth, Dorset, United Kingdom

University Hairmyres Hospital

Bothwell, Scotland, United Kingdom

RJAH Orthopaedic Hospital

Oswestry, Shropshire, United Kingdom

Sheffield Teaching Hospital

Sheffield, South Yorksire, 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

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Wrightington Hospital

Wigan, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UK15-TAR-001

Identifier Type: -

Identifier Source: org_study_id