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Efficacy and Safety of NAVIO

NCT04230616 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-03-18

No results posted yet for this study

Summary

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

total knee arthroplasty

total knee arthroplasty

RADIATION

CT scan

The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.

Sponsors & Collaborators

  • Sint-Trudo Hospital

    lead OTHER

Principal Investigators

  • Peter Bollars, Dr. · Orthopedic Association Sint-Trudo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-02-28
Completion
2030-02-28
FDA Device
Yes

Countries

  • Belgium

Study Locations

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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 NCT04230616 on ClinicalTrials.gov