Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- AAOS Foot and Ankle Questionnaire - includes SF-36
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
AAOS Foot and Ankle Questionnaire - includes SF-36
Time Frame: 10 years
Ankle Osteoarthritis Scale
Time Frame: 10 years
Complications
Time Frame: 10 years
AOFAS Ankle-Hindfoot Scale
Time Frame: 10 years
Foot Function Index
Time Frame: 10 years
Radiographs
Time Frame: 10 years
Secondary Outcomes
No secondary outcomes reported