Comparison Between Fixed- Versus Mobile-bearing TKA

NCT ID: NCT00435357

Last Updated: 2013-06-21

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

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-07-31

Brief Summary

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The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.

Detailed Description

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Conditions

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Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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mobile-bearing TKA

Group Type EXPERIMENTAL

mobile-bearing TKA

Intervention Type DEVICE

fixed- bearing TKA

Group Type ACTIVE_COMPARATOR

fixed- bearing TKA

Intervention Type DEVICE

Interventions

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mobile-bearing TKA

Intervention Type DEVICE

fixed- bearing TKA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medial medial femorotibial arthritis requiring an arthroplasty
* Age between 50y and 90y

Exclusion Criteria

* Lateral femorotibial arthritis
* Inflammatory disease
* Stiff knee with flexion under 90°
* Revision TKA
* Previous surgery (except meniscectomy)
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Hospices Civils de Lyon

Principal Investigators

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Philippe Neyret, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Sebastien Lustig

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2005.407

Identifier Type: -

Identifier Source: org_study_id

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