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

Ankle Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00552136
• Other study ID #: CDHA-MG-001
• Status: Recruiting
• Phase: Phase 4
• First received: October 30, 2007
• Last updated: June 2, 2016
• Start date: February 2005
• Est. completion date: April 2020

Study information

• Verified date: June 2016
• Source: Nova Scotia Health Authority
• Contact: Trish Francis, R N
• Phone: 902-473-5993
• Email: francisp[@]cdha.nshealth.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Arthritis
• Arthritis

Intervention

Procedure:
• Ankle Arthroplasty

• Ankle Arthrodesis

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
Ross Leighton	Canadian Orthopaedic Foot and Ankle Society, Johnson & Johnson, Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AAOS Foot and Ankle Questionnaire - includes SF-36		10 years	No
Primary	AOFAS Ankle-Hindfoot Scale		10 years	No
Primary	Ankle Osteoarthritis Scale		10 years	No
Primary	Foot Function Index		10 years	No
Primary	Radiographs		10 years	No
Primary	Complications		10 years	No