Visionaire: A Prospective Study

The Hawkins Foundation

Status: Terminated

Conditions: Osteoarthritis

Treatments: Other: Visionaire system (Knee MRI); Other: No Knee MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01937572

Pro00013735

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

Computer-aided TKA

Experimental group

Description:

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.

Treatment:

Other: Visionaire system (Knee MRI)

Conventional TKA

Other group

Description:

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.

Treatment:

Other: No Knee MRI