Navio Robotic Versus Conventional Total Knee Arthroplasty

Study Purpose

Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.

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	40 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- age between 40 and 85.

- body mass index (BMI) less than 40.0 kg/m^2.

- end-stage knee osteoarthritis (Kellgren and Lawrence grade 4) - failure of a minimum 12 weeks of nonoperative management.

- English fluency.

Exclusion Criteria:

- history of inflammatory arthropathy in the same knee.

- history of prior open knee surgery in the same knee.

- history of prior osteotomy or periarticular fracture.

- deformity > 15 degrees from a neutral mechanical axis.

- gross ligamentous incompetence of the medial or lateral collateral ligaments.

- musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function.

- unwillingness or inability to participate in the proposed study protocol and follow-up

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.	NCT03519269
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.	Columbia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Herbert John Cooper, MD
Principal Investigator Affiliation	Columbia University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Additional Details

Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. Despite continued improvement in manual instrumentation, postoperative malalignment is still reported in a significant number of patients when these manual instruments are used. Robotic-assisted TKA was developed specifically to improve surgical accuracy, and has been shown to significantly improve accuracy of alignment and joint-line restoration. However, these improvements came at the cost of higher complication rates and were not shown to translate into meaningful clinical outcomes with these first-generation systems. Newer-generation robotic technology offers several advantages over earlier versions including the potential to dynamically assess soft tissues over a range of motion and the ability to use haptic control in bone preparation. Modern robotic-assisted knee surgery has also demonstrated superior outcomes over conventional instrumentation in unicompartmental knee arthroplasty (UKA). This newer-generation of robotic technology, which has quickly become the standard-of-care for many knee surgeons who perform UKA, has recently been approved by the United States Food and Drug Administration (FDA) for use in TKA. Prior to consideration of widespread adoption of this newer technology in patients undergoing TKA, well-designed clinical trials are necessary to study its efficacy in this population. The proposed study evaluates the efficacy of robotic-assistance in patients between 40 and 85 years old with end-stage knee osteoarthritis or degenerative joint disease undergoing TKA. It is designed as a prospective, randomized trial where patients are blinded to their treatment arm. Patients will be randomized to conventional vs.#46; robotically-assisted techniques in the operating room and, other than the surgical technique, will receive the same perioperative care and identical implants. The investigators aim to measure utility of robotic-assisted TKA through a range of early and short-term clinical, functional, and radiographic outcome measures.

Arms & Interventions

Arms

No Intervention: Non robotics-assisted Surgical System

Conventional, non-robotics-assisted total knee surgical system

Experimental: Navio™ Robotics-assisted Surgical System

Navio™ Robotics-assisted Surgical System

Interventions

Device: - Navio™ Robotics-assisted Surgical System

Intervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty

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.

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Site Contact

Herbert John Cooper, MD

[email protected]

212-305-6959

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