What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, particularly surgical interventions like total knee arthroplasty, can have side effects such as infection, blood clots, and implant-related issues like loosening or wear over time. Non-surgical treatments, including NSAIDs, may cause gastrointestinal issues, cardiovascular risks, and kidney problems. Intraarticular injections, such as glucocorticoids, can lead to joint infection, increased pain, and cartilage damage with repeated use. Non-pharmacological treatments like braces and walking aids generally have minor side effects, including discomfort and skin irritation.

What prior FDA approvals exist?

FDA-approved treatments for osteoarthritis, particularly in the context of knee prosthetics, include various knee replacement systems designed to enhance stability and promote bone ingrowth. The Advance Porous Fixed Bearing Tibial Baseplate is an example of such a system, providing a durable foundation for knee prosthetics. Other FDA-approved treatments for osteoarthritis include medications like NSAIDs for pain management and intraarticular injections such as corticosteroids and hyaluronic acid for temporary relief. These treatments aim to manage symptoms and improve joint function, with surgical interventions offering long-term solutions for severe cases.

What other types of research exist?

Promising alternatives to the Advance Porous Fixed Bearing Tibial Baseplate for osteoarthritis patients include: 1) Floating platform mobile-bearing (MB) prostheses, which have shown comparable early clinical outcomes to fixed-bearing systems, potentially offering better range of motion and patient satisfaction. 2) Hydroxyapatite-coated tibial baseplates, which promote bone ingrowth and long-term fixation. 3) Modular systems with advanced materials and designs that enhance stability and reduce wear, such as those incorporating highly cross-linked polyethylene or advanced ceramics.

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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 below

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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:

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I am expected to have knee replacement surgery on the other knee within a year.

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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.

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I need surgery for bone defects using specific implants.

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I have a type of joint inflammation.

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I have had my kneecap surgically removed.

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I have PCL deficiency.

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I have or had an infection.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 2 years for reporting.

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 more

Awards & 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.

0 / 11Eligibility criteria met

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.