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Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

NCT ID: NCT01751334

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-08-31

Brief Summary

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The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

Detailed Description

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Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.

Conditions

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Osteoarthritis

Keywords

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Arthroplasty Replacement Knee Rotational Alignment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobile Bearing

Mobile bearing total knee arthroplasty

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type DEVICE

Mobile Bearing Total knee Arthroplasty

Fixed Bearing

Fixed Bearing total knee arthroplasty

Group Type ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type DEVICE

Fixed Total Knee Arthroplasty

Interventions

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total knee arthroplasty

Mobile Bearing Total knee Arthroplasty

Intervention Type DEVICE

total knee arthroplasty

Fixed Total Knee Arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA

Eligibility Criteria

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Inclusion Criteria

* Primary osteoarthritis

Exclusion Criteria

* infection
* inflammatory arthritis
* reoperation
* severe deformity
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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Sahnghoon Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Role: STUDY_CHAIR

Other Identifiers

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SNUHOSKNEE01-RPFLPSF

Identifier Type: -

Identifier Source: org_study_id