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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2009 by Capital District Health Authority, Canada
Sponsor:
Collaborators:
Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00552136
First received: October 30, 2007
Last updated: March 6, 2012
Last verified: May 2009

October 30, 2007
March 6, 2012
February 2005
Not Provided
  • 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 ] [ Designated as safety issue: Yes ]
  • 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: Open Label
Primary Purpose: Treatment
Ankle Arthritis
  • Procedure: Ankle Arthroplasty
  • Procedure: Ankle Arthrodesis
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
April 2020
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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
Both
18 Years and older
Not Provided
Contact: Trish Francis, R N 902-473-5993 francisp@cdha.nshealth.ca
Canada
 
NCT00552136
CDHA-MG-001
Not Provided
Capital District Health Authority, Canada
Capital District Health Authority, Canada
  • Canadian Orthopaedic Foot and Ankle Society
  • Johnson & Johnson
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
Capital District Health Authority, Canada
May 2009

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