Text Size

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
  Purpose

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 Intervention Phase
Osteoarthritis of Knee
 Device: Mobile bearing
Device: Fixed bearing
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Rotational Angle Between Femur and Tibia [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knee Society Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: November 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01027819     History of Changes
Other Study ID Numbers: SNUHOSK09MBFB, SNUHOSK09MBFB
Study First Received: December 7, 2009
Results First Received: March 6, 2011
Last Updated: December 13, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013