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

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013