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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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Mokdong Hospital
  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

ClinicalTrials.gov processed this record on March 01, 2015