Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
All Genders
Healthy Volunteers
NCT03519269

Navio Robotic Versus Conventional Total Knee Arthroplasty

Led by Columbia University · Updated on 2025-09-08

86

Participants Needed

1

Research Sites

397 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

S

Smith & Nephew, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Navio Robotic Versus Conventional Total Knee Arthroplasty

Who Can Participate

Age: 40Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 85 years
  • Body mass index (BMI) less than 40.0 kg/m^2
  • End-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
  • Failure of at least 12 weeks of nonoperative treatment
  • Ability to speak and understand English
Not Eligible

You will not qualify if you...

  • History of inflammatory arthritis in the same knee
  • Previous open knee surgery on the same knee
  • Prior osteotomy or fracture near the knee
  • Knee deformity greater than 15 degrees from normal alignment
  • Severe ligament instability on the inner or outer side of the knee
  • Other musculoskeletal problems beyond one knee osteoarthritis that significantly limit function
  • Unwillingness or inability to follow the study procedures and attend follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

J

Jacqueline Lenahan, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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