UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of wear resistance,clinical result and radiological course between the cross-linked polyethylene-oxidized zirconium bearing couple and the cross-linked polyethylene-almina ceramic bearing couple in primary total hip arthroplasty. -A randomized controlled trial-
Acronym	Comparison of wear resistance between oxidized zirconium and almina ceramic.
Scientific Title	Comparison of wear resistance,clinical result and radiological course between the cross-linked polyethylene-oxidized zirconium bearing couple and the cross-linked polyethylene-almina ceramic bearing couple in primary total hip arthroplasty. -A randomized controlled trial-
Scientific Title:Acronym	Comparison of wear resistance between oxidized zirconium and almina ceramic.
Region	Japan

Condition
Condition	Coxarthrosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This Study aims to compare the linear wear, clinical result and radiological course between oxdized zirconium femoral head and almina ceramic femoral head articulated cross-linked polyethylene liner in primary total hip arthroplasty.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Linear wear of the polyethylene liner(Dual circle technique)
Key secondary outcomes	Radiological course (wear,osteolysis,loosening) Complication,adverse effect Clinical result (Harris Hip Score,UCLA Score)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Oxinium femoral head 12/14
Interventions/Control_2	Ceramic ball head (almina ceramic)
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)The patient indicated total hip arthroplasty owing to osteoarthritis of the hip joint secondary to developmental dysplasia of the hip joint. 2)The patient 75 aged or under. 3)The patient who can be inplanted 28mm diameter of the femoral head. 4)The patient whose UCLA score is 3 or more.
Key exclusion criteria	1)The patient indicated revision (total or partial) hip arthroplasty. 2)The patient who need the all polyethylene cup implantation. 3)The patient recognized not suitable for this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopaedic Surgery
Zip code	247-0061
Address	5-4-17 Dai,kamakura,Kanagawa
TEL	0467-47-2377
Email	mail@skjrc.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Takayanagi
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Department of Orthopaedic Surgery
Zip code	247-0061
Address	5-4-17 Dai,kamakura,Kanagawa
TEL	0467-47-2377
Homepage URL
Email	mail@skjrc.jp

Sponsor
Institute	Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization	Shonan Kamakura Joint Reconstruction Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mirai Iryo Research Center
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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 11 Month 25 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 06 Month 29 Day
Date of IRB
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 11 Month 25 Day
Last modified on	2020 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008010