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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Ankle Arthritis
 Procedure: Ankle Arthroplasty
Procedure: Ankle Arthrodesis
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ]

Study Start Date: February 2005
Estimated Study Completion Date: April 2020
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552136

Contacts
Contact: Trish Francis, R N 902-473-5993 francisp@cdha.nshealth.ca

Locations
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Mark Glazebrook, MD            
Sub-Investigator: Ross K Leighton, MD, FRCS(C)            
Sub-Investigator: David Amirault, MD            
Sponsors and Collaborators
Capital District Health Authority, Canada
Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson
Investigators
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
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00552136     History of Changes
Other Study ID Numbers: CDHA-MG-001
Study First Received: October 30, 2007
Last Updated: March 6, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013