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Procedure

Surgical Treatments for Ankle Arthritis

N/A
Waitlist Available
Led By Tim Daniels, MD
Research Sponsored by Ross Leighton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient tests (questionnaires) show that ankle arthritis is severe
Eighteen (18) or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the success rates of two different ankle surgeries, Total Ankle Arthroplasty and Ankle Arthrodesis, over a 10-year period. The study will investigate

Who is the study for?
This trial is for adults over 18 with ankle arthritis lasting more than six months, who haven't improved despite trying non-surgical treatments like physiotherapy or bracing. Participants must have severe symptoms as shown by questionnaires and be willing to consent to the study.
What is being tested?
The study compares two surgical methods for treating ankle arthritis: Total Ankle Arthroplasty (replacement) versus Ankle Arthrodesis (fusion). It aims to determine which has better long-term success, fewer complications, and a lower rate of additional foot joint problems over ten years.
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection, swelling, difficulty in walking or limited range of motion. Long-term issues could involve wear or loosening of implants in arthroplasty and altered gait mechanics after arthrodesis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ankle arthritis is severe according to recent tests.
Select...
I am 18 years old or older.
Select...
I have had ankle arthritis for over 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Ankle ArtrodesesActive Control1 Intervention
Group II: Ankle ArthroplastyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Ross LeightonLead Sponsor
4 Previous Clinical Trials
216 Total Patients Enrolled
Canadian Orthopaedic Foot and Ankle SocietyOTHER
Johnson & JohnsonIndustry Sponsor
112 Previous Clinical Trials
163,431 Total Patients Enrolled
1 Trials studying Ankle Arthritis
200 Patients Enrolled for Ankle Arthritis
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,312 Total Patients Enrolled
Tim Daniels, MDPrincipal InvestigatorSt. Michael's Hospital (Toronto, Canada)
Johnny Lau, MDPrincipal InvestigatorTorontoWestern Hospital, Toronto Canada
Murry Penner, MDPrincipal InvestigatorBritish Columbia,Canada
Kevin Wing, MDPrincipal InvestigatorBritish Columbia, Canada
Dave Stevens, MDPrincipal InvestigatorWaterloo, Ontario Canada
Peter Dryden, MDPrincipal InvestigatorVictoria, British Columbia Canada
~53 spots leftby Apr 2030
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