UK Infinity, Post-Market Clinical Follow-up Study

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03063593
• Other study ID #: UK15-TAR-001
• Status: Active, not recruiting
• Start date: April 29, 2016
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Degenerative Arthritis
• Osteoarthritis
• Post-traumatic Osteoarthritis

Locations

Country	Name	City	State
United Kingdom	NHS Lanarkshire	Bothwell	Scotland
United Kingdom	Royal Bournemouth Hosptial	Bournemouth	Dorset
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	Middlesex
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	RJAH Hospital NHS FT	Oswestry	Shropshire
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorksire
United Kingdom	Torbay and South Devon NHS Foundation Trust	Torquay	Devon
United Kingdom	Wrightington Hospital	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EQ5D-EuroQol-questionnaire	Compare the improvement in self-reported pain and social interaction for quality of life measures	From pre-op through 10 years
Secondary	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
Secondary	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
Secondary	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