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Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

This study is currently recruiting participants.
Verified June 2016 by Ross Leighton, Nova Scotia Health Authority
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552136
First Posted: November 1, 2007
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson
Nova Scotia Health Authority
Information provided by (Responsible Party):
Ross Leighton, Nova Scotia Health Authority
October 30, 2007
November 1, 2007
June 3, 2016
February 2005
April 2020   (Final data collection date for primary outcome measure)
  • AAOS Foot and Ankle Questionnaire - includes SF-36 [ Time Frame: 10 years ]
  • AOFAS Ankle-Hindfoot Scale [ Time Frame: 10 years ]
  • Ankle Osteoarthritis Scale [ Time Frame: 10 years ]
  • Foot Function Index [ Time Frame: 10 years ]
  • Radiographs [ Time Frame: 10 years ]
  • Complications [ Time Frame: 10 years ]
  • AAOS Foot and Ankle Questionnaire - includes SF-36
  • AOFAS Ankle-Hindfoot Scale
  • Ankle Osteoarthritis Scale
  • Foot Function Index
  • Radiographs
  • Complications
Complete list of historical versions of study NCT00552136 on ClinicalTrials.gov Archive Site
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Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ankle Arthritis
  • Procedure: Ankle Arthroplasty
  • Procedure: Ankle Arthrodesis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2020
April 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Trish Francis, R N 902-473-5993 francisp@cdha.nshealth.ca
Canada
 
 
NCT00552136
CDHA-MG-001
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Ross Leighton, Nova Scotia Health Authority
Ross Leighton
  • Canadian Orthopaedic Foot and Ankle Society
  • Johnson & Johnson
  • Nova Scotia Health Authority
Principal Investigator: Mark Glazebrook, MD Capital District Health Authority, Halifax Canada
Principal Investigator: Tim Daniels, MD St Michael's Hospital Toronto Canada
Principal Investigator: Alistair Younger, MD British Columbia Canada
Principal Investigator: Johnny Lau, MD TorontoWestern Hospital, Toronto Canada
Principal Investigator: Peter Dryden, MD Victoria, British Columbia Canada
Principal Investigator: Murry Penner, MD British Columbia,Canada
Principal Investigator: Kevin Wing, MD British Columbia, Canada
Principal Investigator: Craig Stone, MD Newfoundland, Canada
Principal Investigator: Dave Stevens, MD Waterloo, Ontario Canada
Nova Scotia Health Authority
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP