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Joint Fusion
Gait Analysis for Ankle Arthritis
Phase 4
Waitlist Available
Led By Timothy R. Daniels, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic Ankle Arthritis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing two surgical options for treating hindfoot arthritis: joint fusion and total ankle joint replacement. Researchers are interested in the effect of each surgery on patients' gait and symptoms.
Who is the study for?
This trial is for adults over 40 with ankle arthritis who can consent to participate. It's not for those with severe bone conditions, neuromuscular issues, recent infections, prior ankle surgeries, obesity (BMI >30), or cognitive impairments that affect follow-up.Check my eligibility
What is being tested?
The study compares the walking patterns of patients before and after two different surgical treatments for severe ankle arthritis: hindfoot fusion and total ankle replacement. The goal is to understand how these surgeries impact gait and symptoms like pain and mobility.See study design
What are the potential side effects?
While specific side effects are not listed in this summary, typical risks may include post-surgical pain, swelling at the surgery site, difficulty walking during recovery, potential infection risk, or complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have painful ankle arthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The measure will be micro motion, consisting of component migration and rotation relative to the talus and distal tibia. This will be measured utilizing RSA with bi-planar stereo X-rays taken at several intervals: before weight bearing is
Trial Design
2Treatment groups
Active Control
Group I: Ankle ArthoplastyActive Control1 Intervention
Patients will undergo a Total Ankle Replacement procedure
Group II: Ankle fusionActive Control1 Intervention
Patients will undergo an Ankle Arthrodesis procedure
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
538 Previous Clinical Trials
447,523 Total Patients Enrolled
1 Trials studying Ankle Arthritis
40 Patients Enrolled for Ankle Arthritis
Johnson & JohnsonIndustry Sponsor
105 Previous Clinical Trials
26,209 Total Patients Enrolled
1 Trials studying Ankle Arthritis
100 Patients Enrolled for Ankle Arthritis
Timothy R. Daniels, MDPrincipal InvestigatorUnity Health Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to fuse or replace my ankle joint.I cannot undergo major surgery due to my health condition.I have a severe deformity in my foot on the same side.I have a condition that affects my muscle strength or coordination.My BMI is over 30, indicating obesity.I have not had a serious infection in the last year.I have very weak or brittle bones.I am under 40 years old.I have painful ankle arthritis.I have bone death in my ankle due to lack of blood supply.
Research Study Groups:
This trial has the following groups:- Group 1: Ankle Arthoplasty
- Group 2: Ankle fusion
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation accept individuals over the age of fifty?
"This medical research is open to those aged 40 and above, up until the age of 85."
Answered by AI
Are there still opportunities for patients to join this research endeavor?
"The clinicaltrial.gov page reveals that this medical trial is not currently enrolling new patients, despite being originally posted on June 1st 2002 and recently updated on December 12th 2012. Fortunately, there are 364 other trials in need of participants right now."
Answered by AI
Has Ankle Arthoplasty attained FDA certification?
"With Ankle Arthoplasty having completed Phase 4 of clinical trials, it has been assessed a score 3 for safety due to the treatment's regulatory approval."
Answered by AI
Could I feasibly take part in this clinical experiment?
"This trial requires 200 participants with ankle issues, aged between 40 and 85. Criteria for entry include symptoms of Ankle Arthritis, confirmation of skeletal maturity, and the ability to provide informed consent."
Answered by AI
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