Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

February 24, 2010 updated by: Ewha Womans University

Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study

The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Out comes measures were to determine

  1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.
  2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
  3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis
  4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

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

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PFC sigma RP
Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)
Device: PFC-Sigma RP
Posterior stabilizing rotating platform total knee components
Other Names:
  • PFC sigma RP
Active Comparator: LCS RP
non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana
Device: LPS RP
non-posterior stabilized rotating platform design
Other Names:
  • LCS RP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society knee score
Time Frame: at 3 months, 1 year, than annually
at 3 months, 1 year, than annually

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of motion
Time Frame: at 3 months, 1 year, than annually
at 3 months, 1 year, than annually

Collaborators and Investigators

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

Sponsor

Ewha Womans University

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

May 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-2-16

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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