Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?

NCT ID: NCT01422642

Last Updated: 2011-08-30

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.

Detailed Description

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We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS 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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legacy posterior stabilized high-flexion

NexGen LPS-Flex total knee system

Group Type EXPERIMENTAL

legacy posterior stabilized high-flexion (NexGen LPS-Flex)

Intervention Type DEVICE

NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system

legacy posterior stabilized standard

standard NexGen LPS prosthesis

Group Type EXPERIMENTAL

legacy posterior stabilized standard (NexGen LPS)

Intervention Type DEVICE

NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Interventions

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legacy posterior stabilized high-flexion (NexGen LPS-Flex)

NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system

Intervention Type DEVICE

legacy posterior stabilized standard (NexGen LPS)

NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Intervention Type DEVICE

Other Intervention Names

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NexGen LPS-Flex NexGen LPS

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

48 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Principal Investigators

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Young-Hoo Kim, MD

Role: STUDY_DIRECTOR

Ewha Womans University School of Medicine

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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LPS-Flex vs LPS

Identifier Type: -

Identifier Source: org_study_id

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