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Robotic Surgery

Robot-Assisted vs. Manual Knee Replacement for Osteoarthritis

N/A
Waitlist Available
Led By Matthew P Abdel
Research Sponsored by Mayo Clinic
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 will compare robot-assisted to manually-executed total knee replacement surgery in terms of functional outcomes.

Who is the study for?
This trial is for individuals aged 20-100 with osteoarthritis needing a knee replacement and can consent to the study. It's not for those with severe knee deformities, inflammatory arthritis, previous infections or replacements in the knee, BMI over 40, substance abuse issues, certain communicable diseases or psychiatric conditions.Check my eligibility
What is being tested?
The study compares robot-assisted total knee arthroplasty (replacement) to the traditional manual method to see if there's a difference in how well patients do after surgery.See study design
What are the potential side effects?
While not specified here, typical side effects of knee replacement surgeries may include pain at the site of operation, swelling, blood clots, infection risk and sometimes stiffness or difficulty moving the joint.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic Parameters

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Total Knee Robotically-AssistedExperimental Treatment1 Intervention
The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
Group II: Total Knee Manual-Executed by SurgeonActive Control1 Intervention
Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Robotically-Assisted
2018
N/A
~160

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,899 Total Patients Enrolled
27 Trials studying Osteoarthritis
2,678 Patients Enrolled for Osteoarthritis
Matthew P AbdelPrincipal InvestigatorMayo Clinic

Media Library

Osteoarthritis Clinical Trial 2023: Total Knee Robotically-Assisted Highlights & Side Effects. Trial Name: NCT03482349 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to register for participation in this study?

"This trial will evaluate 142 individuals with arthrosis between the ages of 20 to 100. To be eligible, patients must have been considered for primary TKA, demonstrate capacity to consent and provide informed agreement regarding the study's terms."

Answered by AI

Do adults aged thirty and over qualify for this research experiment?

"According to the criteria for entry, individuals aged 20-100 are eligible. Additionally, 30 trials focus on those below 18 and 583 accommodate senior citizens above 65."

Answered by AI

Is the registration period for this trial still available?

"Per the details listed on clinicaltrials.gov, this study is no longer seeking participants; however, it was first made public in March of 2018 and last edited October 12th 2022. Nevertheless, 613 other trials are currently searching for patients who meet their criteria."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~22 spots leftby Mar 2025