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
Device: total knee arthroplasty
Mobile Bearing Total knee Arthroplasty
Other Names:
  • Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA
Device: total knee arthroplasty
Fixed Total Knee Arthroplasty
Other Names:
  • Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA
Active Comparator: Fixed Bearing
Fixed Bearing total knee arthroplasty
Device: total knee arthroplasty
Mobile Bearing Total knee Arthroplasty
Other Names:
  • Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA
Device: total knee arthroplasty
Fixed Total Knee Arthroplasty
Other Names:
  • Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA

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.

Sponsor

Seoul National University Hospital

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.

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