Computer Assisted Total Knee Replacement
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|ClinicalTrials.gov Identifier: NCT00279838|
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : March 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty Osteoarthritis||Procedure: Computer Assisted Navigation Knee Replacement||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Computer Assisted Navigation in Total Knee Arthroplasty|
|Study Start Date :||June 2004|
|Primary Completion Date :||April 2007|
|Study Completion Date :||April 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279838
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Mary I. O'Connor, M.D.||Mayo Clinic|