Porous Baseplate Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByDouglas Naudie, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Canadian Radiostereometric Analysis Network

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I need a knee replacement due to severe arthritis pain.

I am 21 years old or older.

Exclusion 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.

I need knee replacement surgery on both knees due to deformity.

I need surgery for bone defects using specific implants.

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.

Participant Groups

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.

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.