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Clinical Trials/NCT01937572
NCT01937572TerminatedNot Applicable

Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study

The Hawkins Foundation2 sites in 1 country149 target enrollmentStarted: November 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
149
Locations
2
Primary Endpoint
Knee Society Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Outcomes

Primary Outcomes

Knee Society Score

Time Frame: one year

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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