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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PFC-Sigma RP
LPS RP
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring rotating platform, posterior stabilized, non-posterior stabilized

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PFC sigma RP

LCS RP

Arm Description

Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)

non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana

Outcomes

Primary Outcome Measures

Knee Society knee score

Secondary Outcome Measures

Range of motion

Full Information

First Posted
February 16, 2010
Last Updated
February 24, 2010
Sponsor
Ewha Womans University
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1. Study Identification

Unique Protocol Identification Number
NCT01075620
Brief Title
Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty
Official Title
Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ewha Womans University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
rotating platform, posterior stabilized, non-posterior stabilized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFC sigma RP
Arm Type
Experimental
Arm Description
Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)
Arm Title
LCS RP
Arm Type
Active Comparator
Arm Description
non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana
Intervention Type
Device
Intervention Name(s)
PFC-Sigma RP
Other Intervention Name(s)
PFC sigma RP
Intervention Description
Posterior stabilizing rotating platform total knee components
Intervention Type
Device
Intervention Name(s)
LPS RP
Other Intervention Name(s)
LCS RP
Intervention Description
non-posterior stabilized rotating platform design
Primary Outcome Measure Information:
Title
Knee Society knee score
Time Frame
at 3 months, 1 year, than annually
Secondary Outcome Measure Information:
Title
Range of motion
Time Frame
at 3 months, 1 year, than annually

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoowang Choi, MD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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