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Navio Robotic Versus Conventional Total Knee Arthroplasty

NCT03519269 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DEVICE

Navio™ Robotics-assisted Surgical System

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

Sponsors & Collaborators

Principal Investigators

  • Herbert John Cooper, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519269 on ClinicalTrials.gov