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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014