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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01336595 |
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Date of registration:
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14/04/2011 |
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Primary sponsor: |
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Public title:
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Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
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Scientific title:
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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 |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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331 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01336595 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jang-Won Park, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ewha Womans University Mokdong Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Device: Cobalt-Chrome (Cobalt Chrome Genesis II)
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Device: Zirconium (Zirconium Genesis II)
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Primary Outcome(s)
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Improvement in Knee Society Knee Score
[Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery]
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Secondary Outcome(s)
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Improvement in the range of motion
[Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery]
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Secondary ID(s)
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TKRzirconium
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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