Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

NCT ID: NCT00589485

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Detailed Description

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The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Conditions

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Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Knee Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Simplex® Bone Cement

Intervention Type DEVICE

This arm will utilize Simplex® Bone Cement in total knee replacement.

2

Cobalt™ Bone Cement

Intervention Type DEVICE

This arm utilizes Cobalt™ Bone Cement in total knee replacement.

Interventions

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Simplex® Bone Cement

This arm will utilize Simplex® Bone Cement in total knee replacement.

Intervention Type DEVICE

Cobalt™ Bone Cement

This arm utilizes Cobalt™ Bone Cement in 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

* Infection, sepsis, and 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

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biomet Orthopedics, LLC

Warsaw, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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102-U-012

Identifier Type: -

Identifier Source: org_study_id

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