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

Not Applicable

Active, not recruiting

• Conditions: Ankle Arthritis
• Interventions: Procedure: Ankle Arthroplasty; Procedure: Ankle Arthrodesis

• Registration Number: NCT00552136
• Lead Sponsor: Nova Scotia Health Authority

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

Not available

Study Timeline

• Study Start: 2005-05-30
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Study First Posted: 2007-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle Arthroplasty	Ankle Arthroplasty	-
Ankle Artrodeses	Ankle Arthrodesis	-

Primary Outcome Measures

Name	Time	Method
Radiographs	10 years
AAOS Foot and Ankle Questionnaire - includes SF-36	10 years
Ankle Osteoarthritis Scale	10 years
Complications	10 years
AOFAS Ankle-Hindfoot Scale	10 years
Foot Function Index	10 years

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada