UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005879 |
|---|---|
| Receipt number | R000006496 |
| Scientific Title | Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2024/12/23 11:01:07 |
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Basic information
Public title
Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study
Acronym
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
Scientific Title:Acronym
Wear of OXINIUM on XLPE: Multicenter RCT Study
Region
| Japan |
Condition
Condition
Hip Disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate wear resistance of oxidized zirconium femoral head versus CoCr on cross-linked polyethylene for primary total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Linear wear of polyethylene liner
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of oxidized zirconium alloy femoral head
Interventions/Control_2
Implantation of cobalt-chrome alloy femoral head
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient whose written consent was obtained to participate in the study
2. Patient with indication for THA
3. Patient younger than 75 y.o.
4. Patient able to implant 28mm femoral head
5. Patient with UCLA score higher than 3
6. Patient who has Japanese nationality
Key exclusion 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
Target sample size
1308
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Akiyama |
Organization
Gifu University Hospital
Division name
Orthopaedics
Zip code
501-1194
Address
1-1, Yanagi-to, Gifu-shi, Gifu-ken
TEL
058-230-6000
akiyama.haruhiko.m3@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Taguchi |
Organization
Smith & Nephew K.K
Division name
Clinical Affairs
Zip code
105-5114
Address
14F, South Wing, World Trade Centre Building, 2-4-1 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5403-8811
Homepage URL
wataru.taguchi@smith-nephew.com
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Smith & Nephew K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa
Tel
045-370-7627
ycu_crb@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs032180273
Publication of results
Unpublished
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs032180273
Number of participants that the trial has enrolled
1302
Results
The primary endpoint of polyethylene liner wear at 5 years postoperatively was an average of -0.027 mm in the OX group (420 subject hips) and -0.036 mm in the CoCr group (407 subject hips). No statistically significant difference between the 2 groups (p = 0.6433) was observed.There was no significant difference in PRO (Patient report results: Harris Hip Score, Oxford Hip Score, UCLA Score) between the two groups.
Results date posted
| 2024 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1056 subject hips were included in the analysis, excluding subjects with inappropriate informed consent process or subjects who were not allocated to the intervention. The mean age was 61.5 years, 852 subject hips (80.7%) were female, and the primary diagnosis was secondary osteoarthritis in 748 (70.8%), idiopathic osteonecrosis of the femoral head in 140 (13.3%), primary osteoarthritis in 01 (9.6%), and others in 67 (6.3%).
Participant flow
Between August 2011 and June 2015, 1056 patients were enrolled (excluding 246 excluded from the analysis). 536 and 520 patients were allocated to the OXINIUM femoral head (OX) and cobalt-chromium alloy femoral head (CoCr) groups, respectively, for surgery and follow-up.
Adverse events
No AE attributable to this study were noted.
Outcome measures
Primary Efficacy Variables: Evaluation of linear wear of polyethylene liner at 5 years postoperatively. Clinical success was the significant reduction of linear wear of OXINIUM against CoCr.
Secondary Efficacy Variables:Outcome of Harris Hip Score(HHS), UCLA Score, Oxford Hip Score(OHS), Operation record, AE, X ray, Demography
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006496
