Navio Robotic Versus Conventional Total Knee Arthroplasty

NCT03519269 | Recruiting FDA Device

• 1 other identifier: AAAR6537
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

total knee replacement; robotic surgery

Outcome Measures

Primary Outcomes (2)

• Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  The WOMAC is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Up to 2 years

• Score on the Timed Up and Go Test (TUG)

  The TUG measures the time (in seconds) it takes a patient to rise from an armed chair, walk 3 meters, turn, and return to sitting in the same chair. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e., the more time taken, the more dependent in activities of daily living). Risk for Falls: high risk (\>13.5 seconds), none/low/moderate (\<13.5 seconds).

  Up to 2 years

Secondary Outcomes (3)

• Score on Short-Form 12 Health Questionnaire (SF-12)

  Up to 2 years

• Score on New Knee Society Scores (2011 KSS)

  Up to 2 years

• Score on Global Rating Score of Knee Function (GRS)

  Up to 2 years

Study Arms (2)

Non robotics-assisted Surgical System

NO INTERVENTION

Conventional, non-robotics-assisted total knee surgical system

Navio™ Robotics-assisted Surgical System

EXPERIMENTAL

Navio™ Robotics-assisted Surgical System

Device: Navio™ Robotics-assisted Surgical System

Interventions

Navio™ Robotics-assisted Surgical System DEVICE

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

Navio™ Robotics-assisted Surgical System

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Herbert John Cooper, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Lenahan, BS

CONTACT

212-305-8193; jl5092@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: April 17, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)