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Computer Assisted Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279838
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : March 23, 2011
Sponsor:
Collaborator:
Information provided by:

January 18, 2006
January 20, 2006
March 23, 2011
June 2004
April 2007   (Final data collection date for primary outcome measure)
To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation
Same as current
Complete list of historical versions of study NCT00279838 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Computer Assisted Total Knee Replacement
Computer Assisted Navigation in Total Knee Arthroplasty
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).

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Total Knee Arthroplasty
  • Osteoarthritis
Procedure: Computer Assisted Navigation Knee Replacement
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2007
April 2007   (Final data collection date for primary outcome measure)

Study participants must:

  1. Be over 18 years of age.
  2. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
  3. The subject has given consent to the transfer of his/her information to the sponsor.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00279838
957-04
Not Provided
Not Provided
Not Provided
Not Provided
Mayo Clinic
DePuy Orthopaedics
Principal Investigator: Mary I. O'Connor, M.D. Mayo Clinic
Mayo Clinic
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP