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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01379755
• Other study ID #: singleradius
• Secondary ID: singleradius2
• Status: Active, not recruiting
• Phase: N/A
• First received: June 8, 2011
• Last updated: July 13, 2011
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: June 2011
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 48 Years to 84 Years

Eligibility

Inclusion Criteria:

• followed for a minimum of two years.

Exclusion Criteria:

• Not followed for a minimum of two years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Korea, Republic of	Center for Joint Disease, Chonnam National University Hwasun Hospital	Hwasun-Gun	Jeonnam

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of,