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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022186
Receipt No. R000025536
Scientific Title Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Date of disclosure of the study information 2016/06/06
Last modified on 2019/05/05

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Basic information
Public title Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Acronym Clinical outcome of a novel unidirectional porous tricalcium phosphate
Scientific Title Clinical outcome for a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Scientific Title:Acronym Clinical outcome of a novel unidirectional porous tricalcium phosphate
Region
Japan

Condition
Condition benign bone tumor or bone disease
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical outcome of a novel unidirectional porous tricalcium phosphate applied to bone defects after resection of bone tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Radiograhic evaluation at 4weeks, 8weeks, 3monts, 6months, 9months, 12months after surgery)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1.Application of this material to bone defect after bone resection.
2.CT 3 times, laboratory examination 3 times
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who diagnosed as benign bone tumor
2.Patients who applied this material to bone defect after bone resection.

3.Patients who gave written informed consent
Key exclusion criteria Patients who do not consent to this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishida
Organization Nagoya University Graduate school of Medicine
Division name Department of Orthopaedic Surgery
Zip code 4668550
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL 052-744-1908
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Ikuta
Organization Nagoya University Graduate school of Medicine
Division name Department of Orthopaedic Surgery
Zip code 4668550
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi
TEL 052-744-1908
Homepage URL
Email k-ikuta@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate school of Medicine
Institute
Department

Funding Source
Organization Kuraray
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization iga-sou1@adm.med.nagoya-u.ac.jp
Address IRB of Nagoya University Hospital
Tel 0527412111
Email iga-sou1@adm.med.nagoya-u.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
2016 Year 06 Month 06 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 68
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
2016 Year 06 Month 29 Day
Date of IRB
2016 Year 07 Month 21 Day
Anticipated trial start date
2016 Year 07 Month 21 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025536

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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