NCT00982956

Brief Summary

Objective: The purpose of this study is to evaluate the application of computer-assisted navigation in Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA. Methods: Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and the conventional TKA were separately performed on two knee joints. The operative method and order of the operations were decided on a randomized basis. All the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. Student t test was used for statistical analysis. hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

First QC Date

September 22, 2009

Last Update Submit

September 22, 2009

Conditions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the subjects who had been scheduled for simultaneous bilateral TKA,

You may qualify if:

  • plan for simultaneous bilateral TKA.

You may not qualify if:

  • plan for unilateral TKA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Last Updated

September 23, 2009

Record last verified: 2009-09