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Surgery
Robot-Assisted vs Traditional Knee Replacement for Osteoarthritis
N/A
Waitlist Available
Led By Jeremy Reid, MD
Research Sponsored by Virtua Health, Inc.
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 up to 5 years postoperatively
Awards & highlights
Study Summary
This trial aims to compare outcomes of patients who receive traditional total knee replacement surgery to those who receive robot-assisted surgery. The outcomes tracked include: self-reported awareness of their artificial joints during activities of daily living, pain, function in daily living and recreation, knee-related quality of life, general health perceptions, and limb alignment.
Who is the study for?
This trial is for adults over 18 with primary osteoarthritis who need a knee replacement and can follow the study plan. It's not for pregnant women, those without insurance coverage for certain pre-op procedures, or cases related to worker's compensation/personal injury.Check my eligibility
What is being tested?
The study compares traditional total knee replacement surgery with robot-assisted surgery by measuring patient comfort, pain levels, daily function, sports activity, quality of life, general health perceptions and accuracy of the surgical procedure.See study design
What are the potential side effects?
While not specified in this summary, typical side effects from knee replacement surgeries may include pain at the site of operation, swelling around the knee joint area, stiffness in the operated leg or difficulty moving.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient reported Forgotten Joint Score (FJS)
Secondary outcome measures
Patient reported Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported Veterans Rand 12-item Health Survey Score (VR-12)
The mechanical alignment of the post-operative limb
Trial Design
2Treatment groups
Active Control
Group I: Robot Assisted Total Knee ReplacementActive Control1 Intervention
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
Group II: Traditional Total Knee ReplacementActive Control1 Intervention
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
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Who is running the clinical trial?
Virtua Health, Inc.Lead Sponsor
8 Previous Clinical Trials
418 Total Patients Enrolled
Jeremy Reid, MDPrincipal InvestigatorVirtua Joint Replacement Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a knee injury related to work or personal injury. Clinical outcomes for people with this type of injury are often uncertain and may not be covered by insurance.You have joint damage caused by a previous injury that makes predicting treatment outcomes more difficult.
Research Study Groups:
This trial has the following groups:- Group 1: Robot Assisted Total Knee Replacement
- Group 2: Traditional Total Knee Replacement
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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03523897 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible to partake in this investigation?
"Affirmative. According to information housed on clinicaltrials.gov, this medical research project is presently recruiting participants. It was initially posted in April of 2018 and last modified in April 2022. The trial seeks 248 volunteers at a single site for enrolment."
Answered by AI
Are there any volunteers currently being accepted for this clinical trial?
"According to the clinicaltrials.gov listing, this experiment is persisting in its search for participants. It was initially made available on April 20th 2018 and underwent its last update on April 25th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
Virtua Joint Replacement Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm scheduled for a traditional knee replacement in early Sept.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What all is involved and how long are the sessions?
PatientReceived 1 prior treatment
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