Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial

NCT ID: NCT01312532

Last Updated: 2011-03-10

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

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Detailed Description

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Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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fixed-bearing

fixed-bearing device is a kind of prosthesis

Group Type OTHER

fixed-bearing (P.F.C.® Sigma)

Intervention Type DEVICE

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

mobile-bearing

mobile-bearing device is a kind of prosthesis

Group Type OTHER

mobile-bearing (P.F.C.® Sigma)

Intervention Type DEVICE

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

Interventions

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fixed-bearing (P.F.C.® Sigma)

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

Intervention Type DEVICE

mobile-bearing (P.F.C.® Sigma)

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with expected primary total knee arthroplasty

Exclusion Criteria

* Mediolateral instability
* Infective arthritis
* Severe deformity
* Revision
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isfahan University of Medical Sciences

Principal Investigators

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mohammad dehghani, A.Professor

Role: STUDY_CHAIR

Isfahan University of Medical Sciences

Locations

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Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-1213-17

Identifier Type: -

Identifier Source: org_study_id

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