Trials Sponsors Conditions Drugs Pricing

Conditions

Arthritis, Rheumatoid Degenerative Arthritis Post-traumatic Osteoarthritis

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

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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:

Sponsors & Collaborators

Stryker Trauma and Extremities
Industrylead

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

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB, United Kingdom

North Bristol NHS Trust Southmead Hospital

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

David Townshend, MD
Northumbria Trust
STUDY CHAIR
Rebecca Gibson
Stryker Trauma & Extremeties
STUDY DIRECTOR

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

Actual (reported)

Primary Completion

December 31, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

UK Infinity, Post-Market Clinical Follow-up Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations