Partial Knee Replacement for Osteoarthritis

Overseen By JIS Research Institute

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JIS Research Institute

Must not be taking: Immunosuppressives, Steroids

Disqualifiers: Rheumatoid arthritis, Osteoporosis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

108 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

David A Crawford, MD

Principal Investigator

JIS Research Institute

Are You a Good Fit for This Trial?

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

Patients with BMI < 40

Patients who are able to follow post operative care instructions

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

Exclusion Criteria

Participation in an interventional clinical research study procedure, other than a bilateral knee arthroplasty in this study, within the past 12 months

Prisoners or, individuals who are known to be abusing drugs or alcohol or are mentally incompetent

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo unicompartmental knee arthroplasty with either cemented or cementless fixation

6 weeks

1 visit (surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain score, implant survivorship, range of motion, and KOOS JR score

24 months

6 visits (in-person) at 6 weeks; 3, 6, 9, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Engage Partial Knee

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

JIS Research Institute

Lead Sponsor

Trials

1

Recruited

110+

Smith & Nephew, Inc.

Industry Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley