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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 year post-operative analysis
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 year post-operative analysis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 year post-operative analysis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Equivalence in 1 year post-operative mean Range of Motion (ROM) in subjects receiving the J II CR TKS as compared to the literature reference mean ROM
Non-inferiority of the survival rate of the J II CR TKS with the reference survival rate of a literature reference at 5 and 10-years post-operatively
Secondary outcome measures
Clinical Outcomes: 2011 Knee Society Score (2011 KSS) clinical evaluation
Clinical Outcomes: EuroQol 5D (EQ-5D) scale
Clinical Outcomes: Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty (SAPSS
+7 moreTrial 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
Find a Location
Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,311 Total Patients Enrolled
31 Trials studying Osteoarthritis
4,468 Patients Enrolled for Osteoarthritis
Rebecca McDonaldStudy ChairSmith & Nephew, Inc.
Sobia ParveenStudy ChairSmith & Nephew, Inc.
1 Previous Clinical Trials
126 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for enrollees in this experiment?
"Data hosted on clinicaltrials.gov reveals that this trial is no longer recruiting participants, with the last update to its status having been made in June of 2022. Nonetheless, 693 other trials are currently enrolling candidates at this time."
Answered by AI
How many venues are currently hosting this experiment?
"Rush University Medical Center in Chicago, Orthopedic Institute of the West in Phoenix, and Wake Forest University in Winston-Salem are some of the 6 sites currently accepting patients for this trial."
Answered by AI
Are seniors over the age of 70 excluded from this clinical trial?
"This research endeavour is open to individuals who are between 22 and 75 years old."
Answered by AI
Could I potentially qualify for this research experiment?
"The clinical trial is accepting 170 applicants who suffer from osteoarthritis in their knees, and are aged between 22 to 75 years old."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
New York
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Orthopedic Institute of the West
Center for Hip and Knee Replacement at Columbia University Medical Center
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’ve tried several meds without too much relief in euflexa injections which only work on my right knee but not much on the left knee so I need help with all this pain it’s unbearable!!
PatientReceived 2+ prior treatments
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