Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankle Arthritis
Intervention: Ankle Arthroplasty (Procedure); Ankle Arthrodesis (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Capital District Health Authority, Canada Official(s) and/or principal investigator(s):
Mark Glazebrook, MD, Principal Investigator, Affiliation: Capital Health, Canada
Overall contact:
Kelly Trask, B.Eng., MSc, CCRP, Phone: 902-473-3161, Email: kelly.trask@cdha.nshealth.ca
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.
Clinical Details
Official title: Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Primary outcome: AAOS Foot and Ankle Questionnaire - includes SF-36AOFAS Ankle-Hindfoot Scale Ankle Osteoarthritis Scale Foot Function Index Radiographs Complications
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kelly Trask, B.Eng., MSc, CCRP, Phone: 902-473-3161, Email: kelly.trask@cdha.nshealth.ca
QEII Health Sciences Centre, Halifax, Nova Scotia B3H 3A7, Canada; Recruiting
Mark Glazebrook, MD, Principal Investigator
Ross K Leighton, MD, FRCS(C), Sub-Investigator
David Amirault, MD, Sub-Investigator
Additional Information
Starting date: February 2005
Last updated: October 30, 2007
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