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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
Must not have
Expected to receive contralateral TKA within 1 year
Known medical condition limiting patient life expectancy to less than 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial involves patients undergoing knee replacement surgery using new parts designed to fit and function like natural knee components. The study will monitor how well these parts stay in place and how patients recover over time. It aims to ensure the new parts are effective and safe for people needing knee replacements.
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.
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.
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.
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I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am expected to have knee replacement surgery on the other knee within a year.
Select...
My doctor expects me to live more than 2 years.
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I need knee replacement surgery on both knees due to deformity.
Select...
I need surgery for bone defects using specific implants.
Select...
I have a type of joint inflammation.
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I have had my kneecap surgically removed.
Select...
I have PCL deficiency.
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I have or had an infection.
Select...
I cannot undergo major surgery due to my health condition.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change between 6 months and 1-year post-operative - tibial baseplate stability
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for osteoarthritis (OA) include pharmacologic options like analgesics (e.g., acetaminophen) and NSAIDs (e.g., ibuprofen, naproxen) that reduce pain and inflammation. Glucocorticoids are also used for their anti-inflammatory effects.
Non-pharmacologic treatments involve physical therapy, weight management, and surgical interventions such as total knee arthroplasty (TKA). The Advance Porous Fixed Bearing Tibial Baseplate in TKA provides a stable and durable foundation for knee prosthetics, promoting bone ingrowth and long-term fixation.
This is important for OA patients as it can significantly alleviate pain, improve joint function, and enhance overall quality of life.
Injections in the osteoarthritic knee: a review of current treatment options.
Injections in the osteoarthritic knee: a review of current treatment options.
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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.
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