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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01027819
Recruitment Status : Unknown
Verified December 2012 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2009
Results First Posted : April 5, 2011
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Knee Device: Mobile bearing Device: Fixed bearing Phase 4

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
Study Start Date : November 2009
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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 Name: 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 Name: Zimmer LPS-flex fixed bearing in polyethylene insert



Primary Outcome Measures :
  1. Rotational Angle Between Femur and Tibia [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Knee Society Score [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027819


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Myung Chul Lee, M.D., Ph. D.

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01027819     History of Changes
Other Study ID Numbers: SNUHOSK09MBFB
SNUHOSK09MBFB ( Other Identifier: Seoul national university hospital )
First Posted: December 9, 2009    Key Record Dates
Results First Posted: April 5, 2011
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Seoul National University Hospital:
Total knee arthroplasty
Mobile bearing
Fixed bearing
Range of motion
Knee Society Score

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases