Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty
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.
|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|
- Knee Society knee score [ Time Frame: at 3 months, 1 year, than annually ] [ Designated as safety issue: No ]
- Range of motion [ Time Frame: at 3 months, 1 year, than annually ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075620
|Korea, Republic of|
|Ewha Womans University Mokdong Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Yoowang Choi, MD||Ewha Womans University Mokdong Hospital|