A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03523897
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Virtua Health, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeremy Reid, MD
Principal Investigator Affiliation Virtua Joint Replacement Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Primary Osteoarthritis of Knee Nos
Arms & Interventions

Arms

Active Comparator: 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.

Active Comparator: 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.

Interventions

Procedure: - 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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virtua Joint Replacement Institute, Voorhees, New Jersey

Status

Recruiting

Address

Virtua Joint Replacement Institute

Voorhees, New Jersey, 08043

Site Contact

Jeremy Reid, MD

[email protected]

609-267-9400