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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 23, 2014