Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

NCT ID: NCT01075620

Last Updated: 2010-02-25

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Detailed Description

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Out comes measures were to determine

1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.
2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis
4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Conditions

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Osteoarthritis

Keywords

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rotating platform posterior stabilized non-posterior stabilized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PFC sigma RP

Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)

Group Type EXPERIMENTAL

PFC-Sigma RP

Intervention Type DEVICE

Posterior stabilizing rotating platform total knee components

LCS RP

non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana

Group Type ACTIVE_COMPARATOR

LPS RP

Intervention Type DEVICE

non-posterior stabilized rotating platform design

Interventions

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PFC-Sigma RP

Posterior stabilizing rotating platform total knee components

Intervention Type DEVICE

LPS RP

non-posterior stabilized rotating platform design

Intervention Type DEVICE

Other Intervention Names

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PFC sigma RP LCS RP

Eligibility Criteria

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Inclusion Criteria

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Ewha Womans University Mokdong Hospital Joint Replacement Center

Principal Investigators

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Yoowang Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2010-2-16

Identifier Type: -

Identifier Source: org_study_id