Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
December 13, 2012 updated by: Seoul National University Hospital
The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded.
This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary osteoarthritis
Exclusion Criteria:
- infection
- inflammatory arthritis
- reoperation
- severe deformity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile Bearing
Mobile bearing total knee arthroplasty
|
Mobile Bearing Total knee Arthroplasty
Other Names:
Fixed Total Knee Arthroplasty
Other Names:
|
|
Active Comparator: Fixed Bearing
Fixed Bearing total knee arthroplasty
|
Mobile Bearing Total knee Arthroplasty
Other Names:
Fixed Total Knee Arthroplasty
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tibial anteroposterior axis relative to femoral anteroposterior axis
Time Frame: postoperative 2 weeks
|
Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images
|
postoperative 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sahnghoon Lee, M.D., Ph.D.
- Study Chair: Myung Chul Lee, M.D., Ph.D.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
December 13, 2012
First Posted (Estimate)
December 18, 2012
Study Record Updates
Last Update Posted (Estimate)
December 18, 2012
Last Update Submitted That Met QC Criteria
December 13, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUHOSKNEE01-RPFLPSF
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.