Osteoarthritis > Engage Partial Knee

Partial Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen By David A Crawford, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: JIS Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.

Eligibility Criteria

This trial is for adults over 21 with severe knee osteoarthritis or avascular necrosis limited to one part of the knee, who haven't found relief through other treatments and have a BMI under 40. They must be able to follow post-op care and return for check-ups. Excluded are those with certain diseases, previous knee surgeries that failed, allergies to metal or cement, pregnant women, drug abusers, heavy smokers, or anyone unlikely to complete the study.

Inclusion Criteria

I am having knee replacement surgery on one or both knees.

I have severe cartilage damage in my knee.

My knee function score is below 70.

I have severe osteoarthritis or bone death in my knee's inner side.

My ACL and PCL in my knee are healthy and working well.

My joint cannot fully straighten, but the bend is less than 15 degrees.

Exclusion Criteria

I have had both of my knees partially replaced, either at the same time or in stages.

I refuse to sign the consent form for the study.

I have had my kneecap surgically removed.

I have been diagnosed with rheumatoid arthritis or another inflammatory joint disease.

My bones are still growing.

I have a permanent knee deformity.

I am currently taking medication to suppress my immune system.

My BMI is 40 or higher.

My knee on the side of my upcoming surgery is fused and cannot bend.

I have long-term kidney disease.

I have received an organ transplant.

I need surgery to replace the surface of my kneecap.

My cancer affects the bones that support my body.

I have had an above-knee amputation on the opposite leg and my remaining leg cannot support a prosthesis due to instability or deformity.

I was found to have inadequate bone or conditions unsuitable for partial knee replacement.

I am 80 years old or older.

My joint cannot fully straighten, bending more than 15 degrees.

My knee bends inward more than 15 degrees and cannot be straightened.

I have arthritis from a past knee injury.

I need a device to fix a failed artificial body part.

I have had a bone infection or severe infection in my knee.

I do not have conditions like Sickle Cell, muscle weakness, or bone diseases that could affect a surgery outcome.

I am a smoker or have smoked within the last year.

I am under 21 years old at the time of my surgery.

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

My knee is severely bent inward or outward, needing surgery to correct it.

I have been diagnosed with Parkinson's or Alzheimer's Disease.

My knee function score is 70 or higher before surgery.

My knee surgery to realign the tibia didn't work.

Participant Groups

The study compares two types of partial knee replacements: one using a cementless Engage Partial Knee System versus another using a cemented version. The goal is to see if the new cementless method works just as well as the traditional cemented approach in relieving pain and improving function.

Group I: Cemented Engage Partial Knee Active Control 1 Intervention

Engage partial knee implanted with bone cement for fixation.

Group II: Cementless Engage Partial Knee Active Control 1 Intervention

Engage partial knee implanted with cementless fixation.

Find A Clinic Near You

Research locations nearby Select from list below to view details:

JIS Research Institute New Albany, OH

Who is running the clinical trial?

JIS Research Institute Lead Sponsor

Smith & Nephew, Inc. Industry Sponsor

References