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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
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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
110 Previous Clinical Trials
163,243 Total Patients Enrolled
1 Trials studying Ankle Arthritis
200 Patients Enrolled for Ankle Arthritis
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