Clinical trial NCT03063593: UK Infinity, Post-Market Clinical Follow-up Study
Official title: UK Multi-Centre, Observational, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis, Rheumatoid
Post-traumatic Osteoarthritis
Degenerative Arthritis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System

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

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

Primary outcomes:
measure: Primary Outcome Measure survivorship at 10 years
timeFrame: 10 Years
Secondary outcomes:
measure: EQ5D-EuroQol-questionnaire
timeFrame: From pre-op through 10 years
measure: Ankle Osteoarthritis Score (AOS)-questionnaire
timeFrame: From Pre-op through 10 years
measure: Manchester Oxford Foot Questionnaire (MOXFQ)-questionnaire
timeFrame: From Pre-op through 10 years
measure: Radiographic evaluation-physician reported questionnaire
timeFrame: From Pre-op through 10 years
Other outcomes:
Locations:
city: Torquay
country: United Kingdom
facility: Torbay and South Devon NHS Foundation Trust
state: Devon
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hosptial
state: Dorset
city: Bothwell
country: United Kingdom
facility: NHS Lanarkshire
state: Scotland
city: Oswestry
country: United Kingdom
facility: RJAH Hospital NHS FT
state: Shropshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorksire
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Middlesex
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: Northumbria Trust
name: David Townshend, MD
role: STUDY_CHAIR
affiliation: Stryker Trauma & Extremeties
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: