Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00982956
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Inclusion Criteria:
      • plan for simultaneous bilateral TKA.
      Exclusion Criteria:
      • plan for unilateral TKA.

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Chinese PLA General Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00982956
      Other Study ID Numbers:
      • 2007023
      First Posted:
      Sep 23, 2009
      Last Update Posted:
      Sep 23, 2009
      Last Verified:
      Sep 1, 2009
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Sep 23, 2009