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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006772
Receipt No. R000008010
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-
Date of disclosure of the study information 2011/11/25
Last modified on 2016/06/28

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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
Middle name
Last name Kazuo Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopaedic Surgery
Zip code
Address 5-4-17 Dai,kamakura,Kanagawa
TEL 0467-47-2377
Email

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

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
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 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
2016 Year 06 Month 28 Day


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

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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