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

Primary Purpose

Ankle Arthritis

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Ankle Arthroplasty

Ankle Arthrodesis

About this trial

This is an interventional treatment trial for Ankle Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

QEII Health Sciences CentreRecruiting

Outcomes

Primary Outcome Measures

AAOS Foot and Ankle Questionnaire - includes SF-36

AOFAS Ankle-Hindfoot Scale

Ankle Osteoarthritis Scale

Foot Function Index

Radiographs

Complications

Secondary Outcome Measures

Full Information

NCT ID

NCT00552136

First Posted

October 30, 2007

Last Updated

June 2, 2016

Sponsor

Ross Leighton

Collaborators

Canadian Orthopaedic Foot and Ankle Society, Johnson & Johnson, Nova Scotia Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT00552136

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2005 (undefined)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ross Leighton

Collaborators

Canadian Orthopaedic Foot and Ankle Society, Johnson & Johnson, Nova Scotia Health Authority

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Ankle Arthroplasty

Intervention Type

Procedure

Intervention Name(s)

Ankle Arthrodesis

Primary Outcome Measure Information:

Title

AAOS Foot and Ankle Questionnaire - includes SF-36

Time Frame

10 years

Title

AOFAS Ankle-Hindfoot Scale

Time Frame

10 years

Title

Ankle Osteoarthritis Scale

Time Frame

10 years

Title

Foot Function Index

Time Frame

10 years

Title

Radiographs

Time Frame

10 years

Title

Complications

Time Frame

10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Trish Francis, R N

Phone

902-473-5993

francisp@cdha.nshealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Glazebrook, MD

Organizational Affiliation

Capital District Health Authority, Halifax Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tim Daniels, MD

Organizational Affiliation

St. Michael's Hospital (Toronto, Canada)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alistair Younger, MD

Organizational Affiliation

British Columbia Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Johnny Lau, MD

Organizational Affiliation

TorontoWestern Hospital, Toronto Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Dryden, MD

Organizational Affiliation

Victoria, British Columbia Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Murry Penner, MD

Organizational Affiliation

British Columbia,Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kevin Wing, MD

Organizational Affiliation

British Columbia, Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Craig Stone, MD

Organizational Affiliation

Newfoundland, Canada

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dave Stevens, MD

Organizational Affiliation

Waterloo, Ontario Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Glazebrook, MD

First Name & Middle Initial & Last Name & Degree

Ross K Leighton, MD, FRCS(C)

First Name & Middle Initial & Last Name & Degree

David Amirault, MD

12. IPD Sharing Statement

Learn more about this trial

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

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