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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
  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: None (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:


Further study details as provided by Ross Leighton, Nova Scotia Health Authority:

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 ]
  • Complications [ Time Frame: 10 years ]

Estimated Enrollment: 100
Study Start Date: February 2005
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Ross Leighton
Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson
Nova Scotia Health Authority
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

Responsible Party: Ross Leighton, Orthopedic Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT00552136     History of Changes
Other Study ID Numbers: CDHA-MG-001
First Submitted: October 30, 2007
First Posted: November 1, 2007
Last Update Posted: June 3, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases