Ankle Arthritis
Conditions
Brief summary
The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.
Interventions
PROCEDUREAnkle Arthroplasty
PROCEDUREAnkle Arthrodesis
Ankle fusion surgery
Sponsors
Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eighteen (18) or older * Known to have ankle arthritis for more than six (6) months * Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved * Patient tests (questionnaires) show that ankle arthritis is severe * Patient willing to take part in the study, including signing consent form after carefully reading it
Exclusion criteria
* Dead Bone in the Ankle * Severe foot or Ankle Deformity * Prior Ankle Fusion or Replacement * Active or Prior Infection in the Ankle * Obesity (greater than 250 lbs) * Medical Conditions precluding safe surgery * Nerve or Muscle disease * Severe osteoporosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AAOS Foot and Ankle Questionnaire - includes SF-36 | 10 years |
| AOFAS Ankle-Hindfoot Scale | 10 years |
| Ankle Osteoarthritis Scale | 10 years |
| Foot Function Index | 10 years |
| Radiographs | 10 years |
| Complications | 10 years |
Countries
Canada
Outcome results
None listed