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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Device: PFC-Sigma RP Device: LPS RP | Phase 4 |
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.
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 |

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
|
- Knee Society knee score [ Time Frame: at 3 months, 1 year, than annually ]
- Range of motion [ Time Frame: at 3 months, 1 year, than annually ]

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Ages Eligible for Study: | 30 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Korea, Republic of | |
Ewha Womans University Mokdong Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Yoowang Choi, MD | Ewha Womans University Mokdong Hospital |
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 |