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Not Applicable

Partial Knee Replacement for Osteoarthritis

N/A
Waitlist Available
Led By David A Crawford, MD
Research Sponsored by JIS Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
Patients with full thickness cartilage loss, with or without bone loss in the medial compartment
Must not have
Patients who have undergone same-day or staged bi-lateral partial knee replacement
Patients who refuse to sign the IRB approved Informed Consent Form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether a new type of knee replacement is as good as the existing one.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, typical side effects from partial knee replacement can include pain at the surgery site, swelling around the knee joint area, stiffness in movement initially after surgery and potential risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having knee replacement surgery on one or both knees.
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I have severe cartilage damage in my knee.
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My knee function score is below 70.
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I have severe osteoarthritis or bone death in my knee's inner side.
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My ACL and PCL in my knee are healthy and working well.
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My joint cannot fully straighten, but the bend is less than 15 degrees.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had both of my knees partially replaced, either at the same time or in stages.
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I refuse to sign the consent form for the study.
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I have had my kneecap surgically removed.
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I have been diagnosed with rheumatoid arthritis or another inflammatory joint disease.
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My bones are still growing.
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I have a permanent knee deformity.
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I am currently taking medication to suppress my immune system.
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My BMI is 40 or higher.
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My knee on the side of my upcoming surgery is fused and cannot bend.
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I have long-term kidney disease.
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I have received an organ transplant.
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I need surgery to replace the surface of my kneecap.
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My cancer affects the bones that support my body.
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I have had an above-knee amputation on the opposite leg and my remaining leg cannot support a prosthesis due to instability or deformity.
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I was found to have inadequate bone or conditions unsuitable for partial knee replacement.
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I am 80 years old or older.
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My joint cannot fully straighten, bending more than 15 degrees.
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My knee bends inward more than 15 degrees and cannot be straightened.
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I have arthritis from a past knee injury.
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I need a device to fix a failed artificial body part.
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I have had a bone infection or severe infection in my knee.
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I do not have conditions like Sickle Cell, muscle weakness, or bone diseases that could affect a surgery outcome.
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I am a smoker or have smoked within the last year.
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I am under 21 years old at the time of my surgery.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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My knee is severely bent inward or outward, needing surgery to correct it.
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I have been diagnosed with Parkinson's or Alzheimer's Disease.
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My knee function score is 70 or higher before surgery.
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My knee surgery to realign the tibia didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Implant Survivorship
KOOS JR Score
Pain Score
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

JIS Research InstituteLead Sponsor
Smith & Nephew, Inc.Industry Sponsor
167 Previous Clinical Trials
21,973 Total Patients Enrolled
33 Trials studying Osteoarthritis
4,625 Patients Enrolled for Osteoarthritis
David A Crawford, MDPrincipal InvestigatorJIS Research Institute

Media Library

Engage Partial Knee (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT05377450 — N/A
Osteoarthritis Research Study Groups: Cemented Engage Partial Knee, Cementless Engage Partial Knee
Osteoarthritis Clinical Trial 2023: Engage Partial Knee Highlights & Side Effects. Trial Name: NCT05377450 — N/A
Engage Partial Knee (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377450 — N/A
~33 spots leftby Dec 2025
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