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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient reported Forgotten Joint Score (FJS)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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