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

This study is currently recruiting participants.

Verified by Capital District Health Authority, Canada, May 2009

First Received: October 30, 2007 Last Updated: May 13, 2009 History of Changes

Sponsor:	Capital District Health Authority, Canada
Collaborators:	Canadian Orthopaedic Foot and Ankle Society Johnson & Johnson
Information provided by:	Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:	NCT00552136

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Surgery

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

Study ID Numbers:	CDHA-MG-001
Study First Received:	October 30, 2007
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00552136 History of Changes
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on February 08, 2010