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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 30, 2007

Last Updated Date

October 30, 2007

Start Date ^†

February 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Condition ^†

Ankle Arthritis

Intervention ^†

Procedure: Ankle Arthroplasty
Procedure: Ankle Arthrodesis

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Kelly Trask, B.Eng., MSc, CCRP

902-473-3161

kelly.trask@cdha.nshealth.ca

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00552136

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Capital District Health Authority, Canada

Collaborators ^††

Canadian Orthopaedic Foot and Ankle Society
Johnson & Johnson

Investigators ^†

Principal Investigator:

Mark Glazebrook, MD

Capital Health, Canada

Information Provided By

Capital District Health Authority, Canada

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.