Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
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|ClinicalTrials.gov Identifier: NCT01336595|
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : October 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Zirconium (Zirconium Genesis II) Device: Cobalt-Chrome (Cobalt Chrome Genesis II)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||April 2011|
Experimental: Zirconium Femoral Component
Oxidized zirconium femoral component of Genesis II TKR system is used.
Device: Zirconium (Zirconium Genesis II)
Oxidized Zirconium femoral component of Genesis II TKR system is used.
Other Name: Zirconium Genesis II
Active Comparator: Cobalt Chrome
Cobalt-Chromium Femoral component of Genesis II system is used.
Device: Cobalt-Chrome (Cobalt Chrome Genesis II)
Cobalt Chrome Femoral Component of Genesis II TKR system is used
Other Name: Cobalt Chrome Genesis II
- Improvement in Knee Society Knee Score [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ]change in knee score will be compared with initial score, until mean follow up of 20 years.
- Improvement in the range of motion [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ]change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.
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): NCT01336595
|Korea, Republic of|
|Ewha Womans University Mokdong Hosptial|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jang-Won Park, MD||Ewha Womans University Mokdong Hospital|