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Orthopedic Implant
Total Knee Replacement for Osteoarthritis
N/A
Waitlist Available
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by post-traumatic arthritis, osteoarthritis, or degenerative arthritis
Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee
Must not have
Has a joint condition that does not require patella resurfacing, has received a TKA or unicondylar arthroplasty, or has inadequate bone stock to support the device
Has hip conditions like receiving contralateral or ipsilateral revision hip arthroplasty, having ipsilateral hip arthritis resulting in flexion contracture, or having received a primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether the JOURNEY™ II CR Total Knee System is safe and effective for people with DJD who need a primary total knee replacement.
Who is the study for?
This trial is for men and women aged 22-75 with knee osteoarthritis needing a total knee replacement. Participants must be in good health, able to walk, read and understand consent forms, complete surveys, and commit to 10 years of follow-up. Exclusions include immune disorders, cancer, severe bone conditions like osteoporosis or Paget's disease, allergies to device materials, certain systemic diseases (like uncontrolled diabetes), BMI over 40, current pregnancy or litigation.
What is being tested?
The JOURNEY™ II CR Total Knee System is being tested for safety and effectiveness in patients with degenerative joint disease requiring knee replacement surgery. The study will track patient outcomes after the implantation of this specific knee system.
What are the potential side effects?
While not specified here, typical side effects from similar surgeries may include pain at the site of operation, swelling around the knee area, infection risk post-surgery which could affect the new joint system's function or require additional treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for knee replacement due to arthritis.
Select...
I am between 22 and 75 years old with knee joint disease.
Select...
I can walk on my own and follow all after-surgery check-up instructions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My knee condition doesn't need a cap replacement, and I've had knee surgery or lack enough bone for the device.
Select...
I have hip issues such as needing or having had hip surgery, arthritis, or a hip replacement that's not fully healed.
Select...
I do not have an immune disorder, cancer, severe bone loss in family, allergies to the study device, or conditions affecting the study's outcome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Device:JOURNEY™ II CR Total Knee System (J II CR TKS)Experimental Treatment1 Intervention
Subjects having TKA with JOURNEY™ II CR Total Knee System
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Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
167 Previous Clinical Trials
21,911 Total Patients Enrolled
32 Trials studying Osteoarthritis
4,455 Patients Enrolled for Osteoarthritis
Sobia ParveenStudy ChairSmith & Nephew, Inc.
1 Previous Clinical Trials
126 Total Patients Enrolled
Rebecca McDonaldStudy ChairSmith & Nephew, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The text states that the plans will be available for ten years after the surgery.I am a candidate for knee replacement due to arthritis.I have osteoarthritis.I am a candidate for knee replacement due to arthritis.I am between 22 and 75 years old with knee joint disease.I can walk on my own and follow all after-surgery check-up instructions.I have issues with my other knee that might affect my study participation.I have hip issues such as needing or having had hip surgery, arthritis, or a hip replacement that's not fully healed.My knee condition doesn't need a cap replacement, and I've had knee surgery or lack enough bone for the device.I do not have an immune disorder, cancer, severe bone loss in family, allergies to the study device, or conditions affecting the study's outcome.I have degenerative arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Device:JOURNEY™ II CR Total Knee System (J II CR TKS)
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.
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