Visionaire: A Prospective Study

NCT ID: NCT01937572

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2017-02-28

Brief 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

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Visionaire system (Knee MRI)

Intervention Type: 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.

Group Type: OTHER

No Knee MRI

Intervention Type: OTHER

Interventions

Visionaire system (Knee MRI)

Intervention Type: OTHER

No Knee MRI

Intervention Type: OTHER

Other Intervention Names

Visionaire

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hawkins Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Burnikel, MD

Role: PRINCIPAL_INVESTIGATOR

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Locations

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Pro00013735

Identifier Type: -

Identifier Source: org_study_id