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

NCT ID: NCT01027819

Last Updated: 2012-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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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

Conditions

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Osteoarthritis of Knee

Keywords

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Total knee arthroplasty Mobile bearing Fixed bearing Range of motion Knee Society Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mobile bearing

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

Group Type ACTIVE_COMPARATOR

Mobile bearing

Intervention Type DEVICE

Mobile bearing in total knee arthroplasty

Fixed bearing

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

Group Type ACTIVE_COMPARATOR

Fixed bearing

Intervention Type DEVICE

Fixed bearing in total knee arthroplasty

Interventions

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Mobile bearing

Mobile bearing in total knee arthroplasty

Intervention Type DEVICE

Fixed bearing

Fixed bearing in total knee arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Zimmer LPS-flex mobile bearing type polyethylene insert Zimmer LPS-flex fixed bearing in polyethylene insert

Eligibility Criteria

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Inclusion Criteria

* primary total knee arthroplasty

Exclusion Criteria

* infection
* severe deformity in knee
* revision
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myung Chul Lee, M.D., Ph. D.

Role: STUDY_DIRECTOR

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUHOSK09MBFB

Identifier Type: OTHER

Identifier Source: secondary_id

SNUHOSK09MBFB

Identifier Type: -

Identifier Source: org_study_id