Comparison of Stability and Outcomes in Single-radius Femoral Component for Total Knee Arthroplasty

July 13, 2011 updated by: Chonnam National University Hospital

Study of Compare Mid-flexion Stability and Clinical Outcomes in Single-radius Femoral Design or Multi-radius Femoral Design.

This is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty.

Study Overview

Status

Unknown

Conditions

Detailed Description

Recently, femoral designs based on a sagittal single radius were designed to allow better mid-flexion stability and extensor function after total knee arthroplasty. The purpose of this study was to compare mid-flexion stability and clinical outcomes in patients that received TKA using either a single-radius femoral design or multi-radius femoral design.

Study Type

Observational

Enrollment (Anticipated)

213

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

  • Korea, Republic of
    • Jeonnam
      • Hwasun-Gun, Jeonnam, Korea, Republic of, 519-809
        • Center for Joint Disease, Chonnam National University Hwasun Hospital

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

48 years to 84 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

56 total knee arthroplasties(TKAs) with a single-radius femoral design (Scorpio NRG) (single-radius(SR) group) and 59 total knee arthroplasties(TKAs) with multiradius femoral design (NexGen CR) (multi-radius(MR) group)

Description

Inclusion Criteria:

  • followed for a minimum of two years.

Exclusion Criteria:

  • Not followed for a minimum of two years.

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

Collaborators and Investigators

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

Sponsor

Chonnam National University Hospital

Investigators

  • Study Director: Jong Keun Seon, Professor, Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea

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

August 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ANTICIPATED)

July 1, 2011

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (ESTIMATE)

June 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • singleradius
  • singleradius2 (OTHER: Chonnam National University Hwasun Hospital)

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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