Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

NCT ID: NCT01335438

Last Updated: 2011-10-05

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

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 Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
3. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
4. whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.

Conditions

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Osteoarthritis

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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Cementless Nexgen CR

Cementless fixation of Nexgen CR TKR

Group Type EXPERIMENTAL

Cementless (Nexgen)

Intervention Type DEVICE

Cementless fixation of Nexgen CR TKR

Cemented Nexgen CR

Cemented fixation of Nexgen CR TKR

Group Type ACTIVE_COMPARATOR

Cemented (Nexgen)

Intervention Type DEVICE

Cemented fixation of Nexgen CR TKR

Interventions

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Cementless (Nexgen)

Cementless fixation of Nexgen CR TKR

Intervention Type DEVICE

Cemented (Nexgen)

Cemented fixation of Nexgen CR TKR

Intervention Type DEVICE

Other Intervention Names

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Cementless Nexgen Cemented Nexgen

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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Young Hoo Kim

OTHER

Sponsor Role lead

Responsible Party

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Young Hoo Kim

Professor and Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jang Won Park, MD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Ewha Womans University Mokdong Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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TKRcementless

Identifier Type: -

Identifier Source: org_study_id