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Robotic and Computer-Assisted Surgery for Osteoarthritis
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial looks at how technologies like computer navigation and robotic-arm assistance can improve knee replacement surgery outcomes by reducing malalignment.
Who is the study for?
Adults with severe knee pain from osteoarthritis, who need a knee replacement and can consent to the study. They should be eligible for specific knee components and able to follow the study's procedures. Those with recent other knee surgeries, active infections, or participating in related studies are excluded.Check my eligibility
What is being tested?
The trial is testing two advanced techniques against traditional methods in total knee arthroplasty: ROSA Knee System (a robotic assistant) and KneeAlign (computer navigation). It aims to compare how well each technique aligns the new knee components.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical surgical risks like infection, bleeding, blood clots, pain at surgery site; plus technology-specific issues such as alignment errors leading to additional surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Implant Positioning
Secondary outcome measures
Health Questionnaire
Joint Motion
Knee Alignment
+9 moreTrial Design
3Treatment groups
Active Control
Group I: ROSAActive Control1 Intervention
Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the ROSA Knee System.
Group II: KneeAlignActive Control1 Intervention
Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using the KneeAlign navigation system.
Group III: ConventionalActive Control1 Intervention
Subjects randomly assigned to this arm will undergo a primary total knee arthroplasty procedure using conventional instrumentation.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,551 Total Patients Enrolled
2 Trials studying Osteoarthritis
132 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had knee replacement surgery on the same side before.I do not have an active infection in my knee.I am willing and able to sign the consent form for this study.I am willing and able to follow the study's schedule and check-ups.I am eligible for a knee replacement with Persona or Legion components.I had knee replacement surgery on the opposite leg within the last 18 months.I have a severe hip condition that greatly limits my movement.I am at least 18 years old.I have severe hip damage due to bone loss.
Research Study Groups:
This trial has the following groups:- Group 1: ROSA
- Group 2: KneeAlign
- Group 3: Conventional
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 is the current upper limit of participants in this trial?
"Affirmative. Information provided on clinicaltrials.gov signifies that this medical study, initially posted February 1st of 2023, is actively recruiting patients. Approximately 300 participants must be enrolled at one trial site."
Answered by AI
Can new participants register for this trial at this time?
"Per the information presented on clinicaltrials.gov, this research is currently recruiting applicants. This trial was first posted to the website on February 1st 2023 and has been updated most recently on November 28th 2022."
Answered by AI
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