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

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01075620
First received: February 16, 2010
Last updated: February 24, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Device: PFC-Sigma RP
Device: LPS RP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Knee Society knee score [ Time Frame: at 3 months, 1 year, than annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of motion [ Time Frame: at 3 months, 1 year, than annually ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: May 2002
Study Completion Date: January 2010
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: LCS RP

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.
  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075620

Locations
Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Yoowang Choi, MD Ewha Womans University
  More Information

No publications provided

Responsible Party: Young-Hoo, Kim M.D. Professor, Ewha Womans University Mokdong Hospital Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01075620     History of Changes
Other Study ID Numbers: 2010-2-16
Study First Received: February 16, 2010
Last Updated: February 24, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
rotating platform
posterior stabilized
non-posterior stabilized

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

ClinicalTrials.gov processed this record on June 17, 2013