Computer Assisted Total Knee Replacement
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).
Total Knee Arthroplasty
Procedure: Computer Assisted Navigation Knee Replacement
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Computer Assisted Navigation in Total Knee Arthroplasty|
- To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
- 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 Start Date:||June 2004|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279838
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Mary I. O'Connor, M.D.||Mayo Clinic|