Recruiting

Navio vs. Conventional

Sponsor:

Columbia University

Code:

NCT03519269

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Navio™ Robotics-assisted Surgical System

Study Details

Brief summary:

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT03519269

Start date

Apr 17, 2019

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Navio™ Robotics-assisted Surgical System

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

Primary outcome measure

  • Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Up to 2 years ]
  • Score on the Timed Up and Go Test (TUG) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Herbert John Cooper, MD

More Information

Sponsor

Columbia University

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Keywords

  • total knee replacement
  • robotic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-08.