This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
arthrodesis using screws and/or a plate
Cartiva Synthetic Cartilage Implant
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
VAS, FAAM, Safety
The individual components of the primary outcome measures will be Visual Analog Scale (VAS) Pain, Foot and Ankle Ability Measure (FAAM) Sports sub-scale score and absence of key safety issues.
Time frame: up to 2 years
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Horizon Health Network
Fredericton, New Brunswick, Canada
Queen Elizabeth Science Centre
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Frimley Park Hospital - Surrey Foot and Ankle Clinic
Frimley, Camberley, United Kingdom
St. George's Hospital
Tooting, London, United Kingdom
Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
Stanmore, Middlesex, United Kingdom
Northern General Hospital NHS Trusts - Sheffield Orthopaedics
Sheffield, South Yorkshire, United Kingdom
...and 2 more locations