Clinical trial NCT00552136: Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Official title: Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Arthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foot and Ankle Society
name: Johnson & Johnson
First posted: 2007-11-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: AAOS Foot and Ankle Questionnaire - includes SF-36
timeFrame: 10 years
measure: AOFAS Ankle-Hindfoot Scale
timeFrame: 10 years
measure: Ankle Osteoarthritis Scale
timeFrame: 10 years
measure: Foot Function Index
timeFrame: 10 years
measure: Radiographs
timeFrame: 10 years
measure: Complications
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority, Halifax Canada
name: Mark Glazebrook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital (Toronto, Canada)
name: Tim Daniels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Canada
name: Alistair Younger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TorontoWestern Hospital, Toronto Canada
name: Johnny Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Victoria, British Columbia Canada
name: Peter Dryden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia,Canada
name: Murry Penner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia, Canada
name: Kevin Wing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newfoundland, Canada
name: Craig Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Waterloo, Ontario Canada
name: Dave Stevens, MD
role: PRINCIPAL_INVESTIGATOR
References: