Visionaire: A Prospective Study

July 2, 2018 updated by: The Hawkins Foundation

Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA

Exclusion Criteria:

  • prior TKA
  • ipsilateral upper tibial or distal femoral osteotomy
  • ipsilateral total hip arthroplasty
  • patient with significant >15o varus or valgus
  • morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Computer-aided TKA
The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient.
Other: Visionaire system (Knee MRI)
Other Names:
  • Visionaire
OTHER: Conventional TKA
A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA.
Other: No Knee MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society Score
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Degrees off normal AP and lateral alignment
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
Total blood loss
Time Frame: two days
two days
Operative time
Time Frame: one day
one day
Operative room setup and turnover times
Time Frame: one day
one day
Procedural cost
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hawkins Foundation

Investigators

  • Principal Investigator: Brian Burnikel, MD, Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 7, 2013

First Posted (ESTIMATE)

September 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00013735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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