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Visionaire: A Prospective Study

NCT01937572 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2018-07-05

No results posted yet for this study

Summary

The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.

1. It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
2. It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.

Conditions

Interventions

OTHER

Visionaire system (Knee MRI)

OTHER

No Knee MRI

Sponsors & Collaborators

  • The Hawkins Foundation

    lead OTHER

Principal Investigators

  • Brian Burnikel, MD · Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01937572 on ClinicalTrials.gov