A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

NCT03523897 | Terminated Results

• 1 other identifier: VirtuaHealth-Mako
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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. 1.Patients' self-reported awareness of their artificial joints during activities of daily living;
2. 2.Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
3. 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. 4.The accuracy of implant placement and limb alignment

Conditions

Primary Osteoarthritis of Knee Nos

Outcome Measures

Primary Outcomes (1)

• Patient Reported Forgotten Joint Score (FJS)

  The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)

  1 year

Secondary Outcomes (3)

• Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)

  1 year

• Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)

  1 year

• The Mechanical Alignment of the Post-operative Limb

  6 weeks postoperatively

Study Arms (2)

Robot Assisted Total Knee Replacement

ACTIVE COMPARATOR

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.

Procedure: Robot Assisted Total Knee Replacement

Traditional Total Knee Replacement

ACTIVE COMPARATOR

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.

Procedure: Traditional Total Knee Replacement

Interventions

Robot Assisted Total Knee Replacement 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

Robot Assisted Total Knee Replacement

Traditional Total Knee Replacement 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

Traditional Total Knee Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
• Willing to provide informed consent, participate in study, and comply with study protocol

You may not qualify if:

• Pregnant or contemplating pregnancy prior to surgery;
• 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)
• 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)
• Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans

Sponsors & Collaborators

• Virtua Health, Inc.: lead

Study Sites (1)

Virtua Joint Replacement Institute

Voorhees Township, New Jersey, 08043, United States

Location

Results Point of Contact

• Title: Dr. Jeremy Reid
• Organization: Virtua Health

jreid@reconstructiveortho.com

8008967326

Study Officials

• Jeremy Reid, MD

  Virtua Joint Replacement Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: May 14, 2018
• Study Start: April 20, 2018
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)