search
Back to results

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

Primary Purpose

Osteoarthritis of Knee

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile bearing
Fixed bearing
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee focused on measuring Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary total knee arthroplasty

Exclusion Criteria:

  • infection
  • severe deformity in knee
  • revision

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mobile bearing

Fixed bearing

Arm Description

Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty

Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty

Outcomes

Primary Outcome Measures

Rotational Angle Between Femur and Tibia

Secondary Outcome Measures

Knee Society Score

Full Information

First Posted
December 7, 2009
Last Updated
December 13, 2012
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01027819
Brief Title
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
Official Title
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
Keywords
Total knee arthroplasty, Mobile bearing, Fixed bearing, Range of motion, Knee Society Score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile bearing
Arm Type
Active Comparator
Arm Description
Mobile bearing type between polyethylene insert and tibial component MB type will be randomly used in total knee arthroplasty
Arm Title
Fixed bearing
Arm Type
Active Comparator
Arm Description
Fixed bearing type between polyethylene insert and tibial component FB type will be randomly used in total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
Mobile bearing
Other Intervention Name(s)
Zimmer LPS-flex mobile bearing type polyethylene insert
Intervention Description
Mobile bearing in total knee arthroplasty
Intervention Type
Device
Intervention Name(s)
Fixed bearing
Other Intervention Name(s)
Zimmer LPS-flex fixed bearing in polyethylene insert
Intervention Description
Fixed bearing in total knee arthroplasty
Primary Outcome Measure Information:
Title
Rotational Angle Between Femur and Tibia
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Knee Society Score
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary total knee arthroplasty Exclusion Criteria: infection severe deformity in knee revision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Chul Lee, M.D., Ph. D.
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs