A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

NCT ID: NCT03523897

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2022-07-14

Brief Summary

This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:

1. Patients' self-reported awareness of their artificial joints during activities of daily living;

2. Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;

3. Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;

4. The accuracy of implant placement and limb alignment

Conditions

Primary Osteoarthritis of Knee Nos

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Robot Assisted Total Knee Replacement

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 Type: ACTIVE_COMPARATOR

Robot Assisted Total Knee Replacement

Intervention Type: PROCEDURE

A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints

Traditional Total Knee Replacement

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.

Group Type: ACTIVE_COMPARATOR

Traditional Total Knee Replacement

Intervention Type: PROCEDURE

A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints

Interventions

Robot Assisted Total Knee Replacement

A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints

Intervention Type: PROCEDURE

Traditional Total Knee Replacement

A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older

2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI

3. Willing to provide informed consent, participate in study, and comply with study protocol

Exclusion Criteria

1. Pregnant or contemplating pregnancy prior to surgery;

2. Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)

3. Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)

4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virtua Health, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Reid, MD

Role: PRINCIPAL_INVESTIGATOR

Virtua Joint Replacement Institute

Locations

Virtua Joint Replacement Institute

Voorhees Township, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

VirtuaHealth-Mako

Identifier Type: -

Identifier Source: org_study_id