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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
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by:
Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Osteoarthritis Procedure: Computer Assisted Navigation Knee Replacement Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Assisted Navigation in Total Knee Arthroplasty
Study Start Date : June 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To compare the frontal alignment of the femoral and tibial components from full length standing radiographs
  2. To compare sagittal alignment of the femoral and tibial components from lateral radiographs
  3. To compare the rotation of the femoral and tibial components from CT Scan.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
DePuy Orthopaedics
Investigators
Principal Investigator: Mary I. O'Connor, M.D. Mayo Clinic

ClinicalTrials.gov Identifier: NCT00279838     History of Changes
Other Study ID Numbers: 957-04
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases