Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty

NCT ID: NCT00954954

Last Updated: 2009-08-07

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-07-31

Brief Summary

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The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

Detailed Description

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A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard

Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses

Group Type ACTIVE_COMPARATOR

Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)

Intervention Type DEVICE

Comparison of different types of knee prosthesis

High-flexion

Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses

Group Type ACTIVE_COMPARATOR

High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Intervention Type DEVICE

Comparison of different types of knee prosthesis

Interventions

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Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)

Comparison of different types of knee prosthesis

Intervention Type DEVICE

High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Comparison of different types of knee prosthesis

Intervention Type DEVICE

Other Intervention Names

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P.F.C Sigma Rotating Platform knee P.F.C Sigma Rotating Platform Flex

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of primary osteoarthritis of knee
* A candidate for total knee replacement arthroplasty

Exclusion Criteria

* A diagnosis other than primary osteoarthritis
* A history of previous open knee surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital Department of Orthopaedic Surgery

Principal Investigators

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Myung Chul Lee, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital Department of Orthopaedic Surgery

Locations

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Seoul National University Hospital Department of Orthopaedic Surgery

Seoul, 28, Yongeon-Dong, Jongno-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUHOSKNEE01-RPRPF

Identifier Type: -

Identifier Source: org_study_id

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