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Main
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Note: This record shows only 22 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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs032180273 |
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Date of registration:
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14/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Wear of OXINIUM on XLPE: Multicenter RCT Study
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Scientific title:
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Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study |
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Date of first enrolment:
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11/07/2011 |
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Target sample size:
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1308 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs032180273 |
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Study type:
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Interventional |
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Study design:
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randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
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Phase:
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4
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Contacts
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Name:
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Haruhiko
Akiyama |
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Address:
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1-1 Yanagido, Gifu city, Gifu
501-1194
Gifu
Japan |
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Telephone:
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+81-58-230-6330 |
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Email:
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hakiyama@gifu-u.ac.jp |
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Affiliation:
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Gifu University Hospital |
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Name:
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Haruhiko
Akiyama |
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Address:
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1-1 Yanagido, Gifu city, Gifu
501-1194
Gifu
Japan |
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Telephone:
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+81-58-230-6330 |
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Email:
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hakiyama@gifu-u.ac.jp |
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Affiliation:
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Gifu University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patient whose written consent was obtained to participate in the study.
2. Patient with indication for THA.
3. Patient aged 20 to 75 years old.
4. Patient able to implant 28mm femoral head.
5. Patient with UCLA score higher than 3.
6. Patient who has Japanese nationality.
Exclusion criteria: 1. Revision THA
2. Implantation of all-polyethylene cup
3. Patient unable to evaluate Oxford Hip Score
4. Patient expected to live less than 5 years, such as cancer patients and severe patients.
Age minimum:
>= 20age old
Age maximum:
<= 75age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis
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Hip osteoarthritis, Rheumatoid arthritis
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Intervention(s)
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Arm A: Oxidized zirconium alloy (OXINIUM) femoral head
Arm B: Standard cobalt chromium alloy head
Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)
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Randomize
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Primary Outcome(s)
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Linear wear of polyethylene liner
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Secondary Outcome(s)
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Case background, X-ray evaluation (Bone form, Implant installation position, Bone reaction), Harris Hip Score, UCLA Score, Oxford Hip Score, Surgical record, Adverse event
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Secondary ID(s)
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UMIN000005879
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Source(s) of Monetary Support
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Smith and Nephew K.K.
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Ethics review
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Status: Approval
Approval date: 11/01/2019
Contact:
ycu_crb@yokohama-cu.ac.jp
Yokohama City University Certified Institutional Review Board
+81-45-370-7627
ycu_crb@yokohama-cu.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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30/11/2022 |
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Date Completed:
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06/09/2021 |
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URL:
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