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Orthopedic Implant
TKA Implants for Osteoarthritis
N/A
Waitlist Available
Led By Isabelle Catelas, PhD, PEng
Research Sponsored by Ottawa Hospital Research Institute
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 baseline (within 1 month of surgery), 6 months post-surgery, and 12 months post-surgery; and versus healthy controls
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the muscle function and quality, as well as the immune response to two different types of knee implants.
Eligible Conditions
- Osteoarthritis
- Knee Inflammation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (within 1 month of surgery), 12 months post-surgery; and versus healthy controls
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline knee extension moment at 6 and 12 months during gait
Change from baseline muscle quality assessed via MRI at 12 months
Change from baseline quadriceps muscle activation at 6 and 12 months during gait
Secondary study objectives
Change in trace metal concentrations from baseline, 12 months, and 24 months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Implant GroupsExperimental Treatment2 Interventions
Group will receive the Smith \& Nephew Journey II knee implant or the Zimmer NexGen LPS-Flex knee implant
Group II: Healthy Control GroupActive Control1 Intervention
Control group that will not be undergoing a total knee arthroplasty
Find a Location
Who is running the clinical trial?
University of OttawaOTHER
221 Previous Clinical Trials
269,574 Total Patients Enrolled
4 Trials studying Osteoarthritis
582 Patients Enrolled for Osteoarthritis
Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,808 Total Patients Enrolled
26 Trials studying Osteoarthritis
188,132 Patients Enrolled for Osteoarthritis
Isabelle Catelas, PhD, PEngPrincipal InvestigatorUniversity of Ottawa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People without any injuries or joint problems in their legs that could affect the way they walk.You have any other health conditions that may affect the way you walk.You have any conditions that cause damage to the joints in your legs, except for osteoarthritis in the knee being studied.You have an ongoing infection or a health condition that affects your immune system, like rheumatoid arthritis, HIV, lupus, being pregnant, or having high platelet levels.
Research Study Groups:
This trial has the following groups:- Group 1: Implant Groups
- Group 2: Healthy Control Group
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.
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