Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Not Applicable
Active, not recruiting
- Conditions
- Ankle Arthritis
- Registration Number
- NCT00552136
- Lead Sponsor
- Nova Scotia Health Authority
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method AAOS Foot and Ankle Questionnaire - includes SF-36 10 years Complications 10 years AOFAS Ankle-Hindfoot Scale 10 years Foot Function Index 10 years Radiographs 10 years Ankle Osteoarthritis Scale 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
QEII Health Sciences Centre🇨🇦Halifax, Nova Scotia, Canada