Visionaire: A Prospective Study

N/ATerminatedNCT01937572

The Hawkins Foundation149 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

149

Conditions

Osteoarthritis

Interventions

Visionaire system (Knee MRI)OTHER

No Knee MRIOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Knee Society Score

Time frame: one year

Secondary Outcomes

Degrees off normal AP and lateral alignment

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.