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

Verified by: Seoul National University Hospital, March 2011
First Received: December 7, 2009 | Last Updated: March 6, 2011 | Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed | Estimated Enrollment: 80
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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...

Brief Summary

Official Title: “Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2006

Detailed Clinical Trial 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

Intervention(s) in this Clinical Trial

  • Device: Mobile bearing vs Fixed bearing
    • Mobile bearing and Fixed bearing of tibial component in total knee arthroplasty

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Mobile bearing
    • Mobile bearing vs Fixed bearing
  • Active Comparator: Fixed bearing
    • Mobile bearing vs Fixed bearing

Outcome Measures for this Clinical Trial

Primary Measures

  • Rotational Angle Between Femur and Tibia
    • Time Frame: 2 weeks
      Safety Issue?: No

Secondary Measures

  • Knee Society Score
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • primary total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Seoul National University Hospital Other

Overall Clinical Trial Officials and Contacts

Myung Chul Lee, M.D., Ph. D. Study Director   

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01027819

Study ID Number: SNUHOSK09MBFB

ClinicalTrials.gov Identifier: NCT01027819

Health Authority: Korea: Institutional Review Board

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01027819