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Orthopedic Implant
Porous Baseplate Knee Replacement for Osteoarthritis
N/A
Waitlist Available
Led By Douglas Naudie, MD
Research Sponsored by Canadian Radiostereometric Analysis Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
Aged 21 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 2 years
Awards & highlights
Study Summary
This trial is testing a new kind of knee replacement surgery.
Who is the study for?
This trial is for adults over 21 with knee osteoarthritis needing a total knee replacement, who can follow the study's procedures and provide consent. It's not for those with inflammatory joint diseases, prior infections, severe obesity (BMI >40), conditions that make surgery risky, or certain knee deformities.Check my eligibility
What is being tested?
The trial tests a new type of tibial baseplate used in cruciate-retaining total knee arthroplasty. Participants will receive this porous baseplate along with compatible components to see how well it works and integrates into the body.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with total knee replacements may include pain at the site, infection risk, blood clots, implant wear or loosening over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a knee replacement due to severe arthritis pain.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change between 6 months and 1-year post-operative - tibial baseplate stability
Secondary outcome measures
Change between 1- and 2-years post-operative - tibial baseplate stability
Establish the post-operative migration pattern of the patellar and femoral components
European Quality of Life (EQ-5D-5L)
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: POROUS TIBIA BASEPLATE W/ JRNY LOCKExperimental Treatment1 Intervention
Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.
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Who is running the clinical trial?
Canadian Radiostereometric Analysis NetworkLead Sponsor
7 Previous Clinical Trials
364 Total Patients Enrolled
3 Trials studying Osteoarthritis
132 Patients Enrolled for Osteoarthritis
Douglas Naudie, MDPrincipal InvestigatorLondon Health Sciences Centre
3 Previous Clinical Trials
106 Total Patients Enrolled
2 Trials studying Osteoarthritis
106 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am expected to have knee replacement surgery on the other knee within a year.My doctor expects me to live more than 2 years.My knee's ligaments are strong enough to keep the back one.I need a knee replacement due to severe arthritis pain.I need knee replacement surgery on both knees due to deformity.I need surgery for bone defects using specific implants.I am 21 years old or older.I have a type of joint inflammation.I have had my kneecap surgically removed.I have PCL deficiency.I have or had an infection.I cannot undergo major surgery due to my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: POROUS TIBIA BASEPLATE W/ JRNY LOCK
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.
Is this research project recruiting participants at the moment?
"Affirmative. Details found on clinicaltrials.gov suggest that recruitment for this medical experiment is underway, with the first post being made April 11th 2022 and last updated November 1st of the same year."
Answered by AI
How many individuals are actively engaged in this clinical experiment?
"Affirmative. Per the information provided on clinicaltrials.gov, this study is currently enrolling participants; it was first posted April 11th 2022 and last updated November 1st 2022 with a requirement of 30 individuals from two sites."
Answered by AI
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