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Computer Assisted Total Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279838
First received: January 18, 2006
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Total Knee Arthroplasty
Osteoarthritis
 Procedure: Computer Assisted Navigation Knee Replacement
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 200
Study Start Date: June 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279838     History of Changes
Other Study ID Numbers: 957-04
Study First Received: January 18, 2006
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013