- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279838
Computer Assisted Total Knee Replacement
Computer Assisted Navigation in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study participants must:
- Be over 18 years of age.
- Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol.
- The subject has given consent to the transfer of his/her information to the sponsor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary I. O'Connor, M.D., Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 957-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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