Back to resultsOutcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthroplasty, Replacement, Knee, Range of Motion
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of primary osteoarthritis of knee
- A candidate for total knee replacement arthroplasty
Exclusion Criteria:
- A diagnosis other than primary osteoarthritis
- A history of previous open knee surgery
Sites / Locations
- Seoul National University Hospital Department of Orthopaedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard
High-flexion
Arm Description
Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses
Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses
Outcomes
Primary Outcome Measures
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT00954954
First Posted
August 5, 2009
Last Updated
August 6, 2009
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00954954
Brief Title
Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty
Official Title
Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.
Detailed Description
A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthroplasty, Replacement, Knee, Range of Motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses
Arm Title
High-flexion
Arm Type
Active Comparator
Arm Description
Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses
Intervention Type
Device
Intervention Name(s)
Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
Other Intervention Name(s)
P.F.C Sigma Rotating Platform knee
Intervention Description
Comparison of different types of knee prosthesis
Intervention Type
Device
Intervention Name(s)
High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
Other Intervention Name(s)
P.F.C Sigma Rotating Platform Flex
Intervention Description
Comparison of different types of knee prosthesis
Primary Outcome Measure Information:
Title
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A diagnosis of primary osteoarthritis of knee
A candidate for total knee replacement arthroplasty
Exclusion Criteria:
A diagnosis other than primary osteoarthritis
A history of previous open knee surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Chul Lee, MD, PhD
Organizational Affiliation
Seoul National University Hospital Department of Orthopaedic Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital Department of Orthopaedic Surgery
City
Seoul
State/Province
28, Yongeon-Dong, Jongno-Gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty
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