Total Knee Replacement With Duracon® and Vanguard™ Prostheses

NCT ID: NCT00588887

Last Updated: 2017-06-21

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

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Detailed Description

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Conditions

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Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Duracon®

Intervention Type DEVICE

This group utilizes the Duracon® prostheses for total knee replacement.

2

Vanguard™

Intervention Type DEVICE

This group will utilize the Vanguard™ prostheses for total knee replacement.

Interventions

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Duracon®

This group utilizes the Duracon® prostheses for total knee replacement.

Intervention Type DEVICE

Vanguard™

This group will utilize the Vanguard™ prostheses for total knee replacement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Patients requiring correction of varus, valgus, or posttraumatic deformity.
* Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria

* Patients with infection, sepsis, or osteomyelitis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Lexington Clinic

OTHER

Sponsor Role collaborator

Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biomet Orthopedics, Inc.

Warsaw, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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105-U-014

Identifier Type: -

Identifier Source: org_study_id

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