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Clinical Trials/NCT00552136
NCT00552136
Active, not recruiting
Not Applicable

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

Nova Scotia Health Authority1 site in 1 country250 target enrollmentMay 30, 2005
ConditionsAnkle Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Arthritis
Sponsor
Nova Scotia Health Authority
Enrollment
250
Locations
1
Primary Endpoint
AAOS Foot and Ankle Questionnaire - includes SF-36
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2005
End Date
April 2030
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

AAOS Foot and Ankle Questionnaire - includes SF-36

Time Frame: 10 years

Ankle Osteoarthritis Scale

Time Frame: 10 years

Complications

Time Frame: 10 years

AOFAS Ankle-Hindfoot Scale

Time Frame: 10 years

Foot Function Index

Time Frame: 10 years

Radiographs

Time Frame: 10 years

Study Sites (1)

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