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Joint Replacement
Ankle Replacement Surgery for Osteoarthritis (Cadence Trial)
N/A
Waitlist Available
Led By Timothy Daniels, MD
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 and 10 years
Awards & highlights
Cadence Trial Summary
This trial will study the safety and effectiveness of a new type of ankle replacement surgery when compared to other methods.
Who is the study for?
This trial is for adults with arthritis or rheumatoid arthritis needing ankle replacement. Candidates must be able to follow up and consent to the study's requirements. Exclusions include severe neurological/vascular diseases, poor wound healing, pregnancy, morbid obesity, material allergies, neuromuscular issues, infections affecting joints, and bone quality compromising conditions.Check my eligibility
What is being tested?
The safety and effectiveness of the Cadence Total Ankle System for primary ankle replacements are being tested in a non-randomized study across multiple centers. The focus is on how well patients do after surgery compared to expected outcomes.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the implant site, infection risk around the new joint, possible allergic reactions to materials used in the system if sensitivity exists.
Cadence Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Implant Survivorship
Relative change of Foot and Ankle Ability Measure (FAAM) compared to baseline
Relative change of Pain compared to baseline
+3 moreCadence Trial Design
1Treatment groups
Experimental Treatment
Group I: Integra® Cadence™ Total Ankle SystemExperimental Treatment1 Intervention
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Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,349 Total Patients Enrolled
31 Trials studying Osteoarthritis
4,506 Patients Enrolled for Osteoarthritis
Timothy Daniels, MDPrincipal InvestigatorUniversity of Toronto
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe nerve or muscle problems that can affect your ability to move.You have a current infection in your body that could affect a joint replacement or you recently had an infection.You have a condition or disease that affects your bones or have a history of bone tumors or abnormalities.You have a condition that could make it difficult for your wounds to heal properly, like having weak or damaged tissue.You are allergic to any of the materials used in the implants.
Research Study Groups:
This trial has the following groups:- Group 1: Integra® Cadence™ Total Ankle System
Awards:
This trial has 1 awards, including:- 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.
Are there still spots available for enrolment in this research study?
"The clinicaltrial.gov page indicates that this medical trial, which was initially published on August 24th 2017, is not accepting participants at present. However, there are 937 other trials in the same area of research actively recruiting patients as we speak."
Answered by AI
How many venues are participating in the trial's implementation?
"The OhioHealth Research Institute in Westerville, Ohio is one of the main testing grounds for this trial. Additionally, Duke University in Durham, North carolina and Providence St. Joseph's and St. Michael's Healthcare in Toronto are also hosting sites for research purposes; 11 additional facilities round out the full list of participating locations."
Answered by AI
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