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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-30

Study Completion Date

2030-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ankle Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ankle Arthroplasty

Group Type ACTIVE_COMPARATOR

Ankle Arthroplasty

Intervention Type PROCEDURE

Ankle Artrodeses

Group Type ACTIVE_COMPARATOR

Ankle Arthrodesis

Intervention Type PROCEDURE

Ankle fusion surgery

Interventions

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Ankle Arthroplasty

Intervention Type PROCEDURE

Ankle Arthrodesis

Ankle fusion surgery

Intervention Type PROCEDURE

Other Intervention Names

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Replacement Fusion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No