Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study - Full Text View

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, April 2007

Sponsors and Collaborators:	Capital District Health Authority, Canada 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

MedlinePlus related topics:

Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

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

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

Primary Outcome Measures:

AAOS Foot and Ankle Questionnaire - includes SF-36
AOFAS Ankle-Hindfoot Scale
Ankle Osteoarthritis Scale
Foot Function Index
Radiographs
Complications

Study Start Date:

February 2005

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: Kelly Trask, B.Eng., MSc, CCRP	902-473-3161	kelly.trask@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 Health, Canada

More Information

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

Study placed in the following topic categories:

Musculoskeletal Diseases

Joint Diseases

Arthritis

ClinicalTrials.gov processed this record on October 07, 2008