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

August 19, 2024 updated by: Nova Scotia Health Authority
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ankle Arthroplasty
Procedure: Ankle Arthroplasty
Other Names:
  • Replacement
Active Comparator: Ankle Artrodeses
Procedure: Ankle Arthrodesis
Ankle fusion surgery
Other Names:
  • Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AAOS Foot and Ankle Questionnaire - includes SF-36
Time Frame: 10 years
10 years
AOFAS Ankle-Hindfoot Scale
Time Frame: 10 years
10 years
Ankle Osteoarthritis Scale
Time Frame: 10 years
10 years
Foot Function Index
Time Frame: 10 years
10 years
Radiographs
Time Frame: 10 years
10 years
Complications
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Johnson & Johnson
Canadian Orthopaedic Foot and Ankle Society

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2005

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimated)

November 1, 2007

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-MG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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