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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005879
Receipt No. 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 2018/12/13

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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
Middle name
Last name Takashi Nakamura
Organization Kyoto Medical Center
Division name Orthopaedics
Zip code
Address 1-1, Fukakusa, Mukaihata-Cho, Fushimi-ku, Kyoto
TEL 03-5403-8259
Email junichi.oyama@smith-nephew.com

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiko Akiyama
Organization Gifu University
Division name Orthopaedics
Zip code
Address 1-1, Yanagi-to, Gifu-shi, Gifu-ken
TEL 058-230-6000
Homepage URL
Email junichi.oyama@smith-nephew.com

Sponsor
Institute Gifu University Hospital
Institute
Department

Funding Source
Organization Smith & Nephew Orthopaedics KK
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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
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
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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