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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01027819
First received: December 7, 2009
Last updated: December 13, 2012
Last verified: December 2012
History of Changes

December 7, 2009
December 13, 2012
November 2009
December 2013   (final data collection date for primary outcome measure)
Rotational Angle Between Femur and Tibia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Postoperative range of motion compared with preoperative status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01027819 on ClinicalTrials.gov Archive Site
Knee Society Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of Knee
  • Device: Mobile bearing
    Mobile bearing in total knee arthroplasty
    Other Name: Zimmer LPS-flex mobile bearing type polyethylene insert
  • Device: Fixed bearing
    Fixed bearing in total knee arthroplasty
    Other Name: Zimmer LPS-flex fixed bearing in polyethylene insert
  • Active Comparator: Mobile bearing
    Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
    Intervention: Device: Mobile bearing
  • Active Comparator: Fixed bearing
    Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty
    Intervention: Device: Fixed bearing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01027819
SNUHOSK09MBFB, SNUHOSK09MBFB
No
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Study Director: Myung Chul Lee, M.D., Ph. D.
Seoul National University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP