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NCT Number: NCT00552136

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ankle Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Arthroplasty

Procedure

Other names: Replacement

Ankle Arthrodesis

Procedure

Ankle fusion surgery

Other names: Fusion

Primary outcomes

  1. AAOS Foot and Ankle Questionnaire - includes SF-36

    Time frame: 10 years

  2. AOFAS Ankle-Hindfoot Scale

    Time frame: 10 years

  3. Ankle Osteoarthritis Scale

    Time frame: 10 years

  4. Foot Function Index

    Time frame: 10 years

  5. Radiographs

    Time frame: 10 years

  6. Complications

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Canadian Orthopaedic Foot and Ankle Society
  • Johnson & Johnson

Registry information

Important dates

Study start
2005
Primary completion
2030
Study completion
2030
First posted
Nov 1, 2007
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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