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Clinical Trials/NCT01937572
NCT01937572
Terminated
Not Applicable

Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study

The Hawkins Foundation1 site in 1 country149 target enrollmentNovember 2011
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
The Hawkins Foundation
Enrollment
149
Locations
1
Primary Endpoint
Knee Society Score
Status
Terminated
Last Updated
7 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
November 2011
End Date
February 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Knee Society Score

Time Frame: one year

Secondary Outcomes

  • Degrees off normal AP and lateral alignment(one year)

Study Sites (1)

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