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

March 9, 2011 updated by: Isfahan University of Medical Sciences

Study of Prosthesis in Total Knee Arthroplasty

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with expected primary total knee arthroplasty

Exclusion Criteria:

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: fixed-bearing
fixed-bearing device is a kind of prosthesis
Device: fixed-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
Other: mobile-bearing
mobile-bearing device is a kind of prosthesis
Device: mobile-bearing (P.F.C.® Sigma)
P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Scoring
Time Frame: five years after surgery
was used for evaluating the function of the knee and high scores indicated better knee function
five years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: five years after surgery
Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain).
five years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Chair: mohammad dehghani, A.Professor, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 9, 2011

Last Verified

June 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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