UMIN ID: UMIN000007309
Registered date:16/02/2012
Wear of 32mm Oxidized Zirconium (OXINIUM) head 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 | 2012/02/01 |
Target sample size | 352 |
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 | Smith & Nephew Orthopaedics |
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Secondary Sponsor | Kurume University Medical Center, Nagasaki Rosai Hospital, Kochi Medical School Hospital |
Source(s) of Monetary Support | Smith & Nephew Orthopaedics |
Secondary ID(s) |
Contact
public contact | |
Name | Masanobu Saito |
Address | 2-1 Kidohigashimachi, Kawachinagano, Osaka Japan |
Telephone | 0721-53-5761 |
msaito@ommc-hp.jp | |
Affiliation | Osaka South Medical Centre Orthopaedics |
scientific contact | |
Name | Masanobu Saito |
Address | 2-1 Kidohigashimachi, Kawachinagano, Osaka Japan |
Telephone | 0721-53-5761 |
msaito@ommc-hp.jp | |
Affiliation | Osaka South Medical Centre Department of Orthopaedic Surgery |