Visionaire: A Prospective Study

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Other: No Knee MRI; Other: Visionaire system (Knee MRI)

• Registration Number: NCT01937572
• Lead Sponsor: The Hawkins Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-09-07
• Study First Posted: 2013-09-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional TKA	No Knee MRI	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.
Computer-aided TKA	Visionaire system (Knee MRI)	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.

Primary Outcome Measures

Name	Time	Method
Knee Society Score	one year

Secondary Outcome Measures

Name	Time	Method
Degrees off normal AP and lateral alignment	one year

Trial Locations

Locations (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System; 🇺🇸 Greenville, South Carolina, United States