Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

December 13, 2012 updated by: Seoul National University Hospital
The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Double blind, randomized prospective study Mobile or fixed bearing of the same company

  • Mobile bearing group : group M
  • Fixed bearing group : group F

Inclusion criteria

  • patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

  • Range of motion
  • Complication

  • Scorings

    • KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

  • Alignment angles in knee
  • Positions of femoral and tibial components
  • Position of patella
  • Radiolucency

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mobile bearing
Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
Device: Mobile bearing
Mobile bearing in total knee arthroplasty
Other Names:
  • Zimmer LPS-flex mobile bearing type polyethylene insert
Active Comparator: Fixed bearing
Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty
Device: Fixed bearing
Fixed bearing in total knee arthroplasty
Other Names:
  • Zimmer LPS-flex fixed bearing in polyethylene insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rotational Angle Between Femur and Tibia
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee Society Score
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: 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

November 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 20, 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

  • SNUHOSK09MBFB (Other Identifier: Seoul national university hospital)

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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