108 Participants Needed

Partial Knee Replacement for Osteoarthritis

JR
Overseen ByJIS Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

DA

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.
See 10 more

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.
See 40 more

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?
2Treatment groups
Active Control
Group I: Cemented Engage Partial KneeActive Control1 Intervention
Engage partial knee implanted with bone cement for fixation.
Group II: Cementless Engage Partial KneeActive Control1 Intervention
Engage partial knee implanted with cementless fixation.

Find a Clinic Near You

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 profile image

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath profile image

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

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