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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.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-jRCTs032180273
Date of registration: 14/03/2019
Prospective Registration: No
Primary sponsor: Akiyama Haruhiko
Public title: Wear of OXINIUM on XLPE: Multicenter RCT Study
Scientific title: Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study
Date of first enrolment: 11/07/2011
Target sample size: 1308
Recruitment status: Complete
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs032180273
Study type:  Interventional
Study design:  randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose  
Phase:  4
Countries of recruitment
Contacts
Name: Haruhiko    Akiyama
Address:  1-1 Yanagido, Gifu city, Gifu 501-1194 Gifu Japan
Telephone: +81-58-230-6330
Email: hakiyama@gifu-u.ac.jp
Affiliation:  Gifu University Hospital
Name: Haruhiko    Akiyama
Address:  1-1 Yanagido, Gifu city, Gifu 501-1194 Gifu Japan
Telephone: +81-58-230-6330
Email: hakiyama@gifu-u.ac.jp
Affiliation:  Gifu University Hospital
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis
Intervention(s)
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)
Randomize
Primary Outcome(s)
Linear wear of polyethylene liner
Secondary Outcome(s)
Case background, X-ray evaluation (Bone form, Implant installation position, Bone reaction), Harris Hip Score, UCLA Score, Oxford Hip Score, Surgical record, Adverse event
Secondary ID(s)
UMIN000005879
Source(s) of Monetary Support
Smith and Nephew K.K.
Secondary Sponsor(s)
Ethics review
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
Results
Results available: Yes
Date Posted: 30/11/2022
Date Completed: 06/09/2021
URL:
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