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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Implant Survivorship
KOOS JR Score
Pain Score
+1 moreTrial 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
165 Previous Clinical Trials
22,373 Total Patients Enrolled
32 Trials studying Osteoarthritis
4,638 Patients Enrolled for Osteoarthritis
David A Crawford, MDPrincipal InvestigatorJIS Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I had a hip replacement less than 18 months ago.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 am having knee replacement surgery on one or both knees.I need surgery to replace the surface of my kneecap.I have severe cartilage damage in my knee.My knee function score is below 70.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 had knee replacement surgery on the other knee less than 18 months ago.I am 80 years old or older.My joint cannot fully straighten, bending more than 15 degrees.I do not have conditions like HIV, Hepatitis, Tuberculosis, or cancer that could limit my participation.My knee bends inward more than 15 degrees and cannot be straightened.I have arthritis from a past knee injury.I need treatment to reduce my knee pain or improve its function.I am 21 years old or older.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 have severe osteoarthritis or bone death in my knee's inner side.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.I am at a high risk of falling.My ACL and PCL in my knee are healthy and working well.I do not have any infections that could increase my risk during the trial.My joint cannot fully straighten, but the bend is less than 15 degrees.My knee's lateral part is too damaged for partial replacement.My knee function score is 70 or higher before surgery.My knee surgery to realign the tibia didn't work.I haven't taken steroids in the past 6 months or had a steroid knee injection in the last 6 weeks.I can come back for all my follow-up appointments.My body's natural alignment can be restored.
Research Study Groups:
This trial has the following groups:- Group 1: Cemented Engage Partial Knee
- Group 2: Cementless Engage Partial Knee
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What qualifications must be met in order to become eligible for this clinical experiment?
"To be eligible for this clinical trial, patients must satisfy the requirements of being between 21 and 80 years old and suffering from osteoarthritis in their knee. The current recruitment goals are to enrol 108 individuals."
Answered by AI
Is admission to this clinical trial still available for potential participants?
"Affirmative, clinicaltrials.gov confirms that this experiment is in search of patients. It was first published on August 29th 2022 and the details were last amended a day later. 108 participants are needed from one medical centre for completion of the trial."
Answered by AI
How many participants are being selected for this medical research?
"Affirmative. Clinicaltrials.gov reveals that this trial, initially posted on August 29th 2022, is currently seeking participants. The study requires 108 individuals from a single medical site for enrollment."
Answered by AI
Does this research study accept participants older than eighty-five years of age?
"To qualify for this medical trial, participants must be 21 to 80 years old. There are 27 clinical trials available for minors and 433 studies tailored toward seniors."
Answered by AI
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