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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chonnam National University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01379755
First received: June 8, 2011
Last updated: July 13, 2011
Last verified: June 2011
  Purpose

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


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Compare Mid-flexion Stability and Clinical Outcomes in Single-radius Femoral Design or Multi-radius Femoral Design.

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Estimated Enrollment: 213
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   48 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

Criteria

Inclusion Criteria:

  • followed for a minimum of two years.

Exclusion Criteria:

  • Not followed for a minimum of two years.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01379755

Locations
Korea, Republic of
Center for Joint Disease, Chonnam National University Hwasun Hospital
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-809
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
Study Director: Jong Keun Seon, Professor Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea
  More Information

No publications provided

Responsible Party: JK Seon, Center for Joint Disease, Chonnam National University Hwasun Hospital
ClinicalTrials.gov Identifier: NCT01379755     History of Changes
Other Study ID Numbers: singleradius, singleradius2
Study First Received: June 8, 2011
Last Updated: July 13, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Chonnam National University Hospital:
stability
single-radius
multi-radius
total knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014