Osteoarthritis
Conditions
Keywords
Total knee arthroplasty (TKA), Computer aided systems
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.
Interventions
OTHERVisionaire system (Knee MRI)
OTHERNo Knee MRI
Sponsors
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score | one year |
Secondary
| Measure | Time frame |
|---|---|
| Degrees off normal AP and lateral alignment | one year |
Other
| Measure | Time frame |
|---|---|
| Total blood loss | two days |
| Operative time | one day |
| Operative room setup and turnover times | one day |
| Procedural cost | one day |
Countries
United States
Outcome results
None listed