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Clinical Trials/NCT00279838
NCT00279838
Completed
Phase 4

Computer Assisted Navigation in Total Knee Arthroplasty

Mayo Clinic1 site in 1 country200 target enrollmentJune 2004

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Mayo Clinic
Enrollment
200
Locations
1
Primary Endpoint
To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Detailed Description

Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation. Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
April 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation

Secondary Outcomes

  • To compare the frontal alignment of the femoral and tibial components from full length standing radiographs
  • To compare sagittal alignment of the femoral and tibial components from lateral radiographs
  • To compare the rotation of the femoral and tibial components from CT Scan.

Study Sites (1)

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