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

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ClinicalTrials.gov Identifier: NCT01075620
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:
Ewha Womans University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Device: PFC-Sigma RP Device: LPS RP Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study
Study Start Date : May 2002
Actual Primary Completion Date : December 2002
Actual Study Completion Date : January 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Knee Society knee score [ Time Frame: at 3 months, 1 year, than annually ]

Secondary Outcome Measures :
  1. Range of motion [ Time Frame: at 3 months, 1 year, than annually ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: January 2010

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