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

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.
whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
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
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 (Adult, Senior)
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


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 September 30, 2016

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