UMIN ID: UMIN000005879
Registered date:01/07/2011
Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Hip Disease |
Date of first enrollment | 2011/07/01 |
Target sample size | 1308 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Implantation of oxidized zirconium alloy femoral head Implantation of cobalt-chrome alloy femoral head |
Outcome(s)
Primary Outcome | Linear wear of polyethylene liner |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Revision THA 2. Implantation of all-polyethylene cup 3. THA case with need to use lateralized and anteverted liner in the pre-op planning 4. Patient unable to evaluate Oxford Hip Score 5. Patient expected to live less than 5 years |
Related Information
Primary Sponsor | Gifu University Hospital |
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Secondary Sponsor | Oita U, Kawasaki Medical U, Gifu U, Keio U, Saitama Medical U, Sapporo Medical U, Chiba U, Miyazaki U, Yamaguchi U, Yokohama City U |
Source(s) of Monetary Support | Smith & Nephew Orthopaedics KK |
Secondary ID(s) |
Contact
public contact | |
Name | Haruhiko Akiyama |
Address | 1-1, Yanagi-to, Gifu-shi, Gifu-ken Japan |
Telephone | 058-230-6000 |
junichi.oyama@smith-nephew.com | |
Affiliation | Gifu University Orthopaedics |
scientific contact | |
Name | Takashi Nakamura |
Address | 1-1, Fukakusa, Mukaihata-Cho, Fushimi-ku, Kyoto Japan |
Telephone | 03-5403-8259 |
junichi.oyama@smith-nephew.com | |
Affiliation | Kyoto Medical Center Orthopaedics |