Navio Robotic Versus Conventional Total Knee Arthroplasty

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03519269
Status
Recruiting
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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Navio™ Robotics-assisted Surgical System — DEVICE
    Intervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty

Study Details

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.

Key Dates

Start date
Apr 17, 2019
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Herbert John Cooper, MD
[email protected]
212-305-6959
Herbert John Cooper, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Medical Center· New York, NY

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