Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

NCT ID: NCT00487565

Last Updated: 2013-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-02-28

Brief Summary

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Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Detailed Description

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Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Conditions

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Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Juvenile Arthritis

Keywords

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Total knee replacement Total knee arthroplasty Osteoarthritis Rheumatoid or other inflammatory arthritis Post-traumatic or juvenile arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LCS Complete Posterior Stabilized knee implant

Total knee arthroplasty with a posterior stabilized implant

Group Type OTHER

Total knee arthroplasty

Intervention Type DEVICE

Total knee arthroplasty using a posterior stabilized implant

Interventions

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Total knee arthroplasty

Total knee arthroplasty using a posterior stabilized implant

Intervention Type DEVICE

Other Intervention Names

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LCS® Complete Posterior Stabilized Mobile-bearing Knee

Eligibility Criteria

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Inclusion Criteria

* M/F
* 18-80
* Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
* Skeletally mature, sufficient bone stock to seat and support prosthesis
* Willing/able return for follow-up.
* Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria

* History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
* Communicable diseases that may limit follow-up
* Medical-legal or workers compensation claims.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tammy O'Dell, EMT, CCRA, CCRC

Role: STUDY_DIRECTOR

DePuy

Locations

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Colorado Joint Replacement

Denver, Colorado, United States

Site Status

Joint Reconstruction Center

Pittsburgh, Pennsylvania, United States

Site Status

Jordan-Young Institute

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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LCS:PS

Identifier Type: -

Identifier Source: secondary_id

06005

Identifier Type: -

Identifier Source: org_study_id