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

NCT00552136 | Active Not Recruiting

• 1 other identifier: CDHA-MG-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Arthritis

Outcome Measures

Primary Outcomes (6)

• AAOS Foot and Ankle Questionnaire - includes SF-36

  10 years

• AOFAS Ankle-Hindfoot Scale

  10 years

• Ankle Osteoarthritis Scale

  10 years

• Foot Function Index

  10 years

• Radiographs

  10 years

• Complications

  10 years

Study Arms (2)

Ankle Arthroplasty

ACTIVE COMPARATOR

Procedure: Ankle Arthroplasty

Ankle Artrodeses

ACTIVE COMPARATOR

Procedure: Ankle Arthrodesis

Interventions

Ankle Arthroplasty PROCEDURE

Also known as: Replacement

Ankle Arthroplasty

Ankle Arthrodesis PROCEDURE

Ankle fusion surgery

Also known as: Fusion

Ankle Artrodeses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Orthopaedic Foot and Ankle Society: collaborator
• Johnson & Johnson: collaborator

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Ankle; Replantation; Gene Fusion

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Transplantation; Recombination, Genetic; Genetic Phenomena

Study Officials

• Mark Glazebrook, MD

  Capital District Health Authority, Halifax Canada

  PRINCIPAL INVESTIGATOR

• Tim Daniels, MD

  St. Michael's Hospital (Toronto, Canada)

  PRINCIPAL INVESTIGATOR

• Alistair Younger, MD

  British Columbia Canada

  PRINCIPAL INVESTIGATOR

• Johnny Lau, MD

  TorontoWestern Hospital, Toronto Canada

  PRINCIPAL INVESTIGATOR

• Peter Dryden, MD

  Victoria, British Columbia Canada

  PRINCIPAL INVESTIGATOR

• Murry Penner, MD

  British Columbia,Canada

  PRINCIPAL INVESTIGATOR

• Kevin Wing, MD

  British Columbia, Canada

  PRINCIPAL INVESTIGATOR

• Craig Stone, MD

  Newfoundland, Canada

  PRINCIPAL INVESTIGATOR

• Dave Stevens, MD

  Waterloo, Ontario Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: November 1, 2007
• Study Start: May 30, 2005
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CA (1)