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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013457
Receipt No. R000015713
Scientific Title Clinical trial of custom-made implant for severe bone defect
Date of disclosure of the study information 2014/03/18
Last modified on 2015/09/02

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Basic information
Public title Clinical trial of custom-made implant for severe bone defect
Acronym Clinical trial of custom-made implant
Scientific Title Clinical trial of custom-made implant for severe bone defect
Scientific Title:Acronym Clinical trial of custom-made implant
Region
Japan

Condition
Condition Severe bone defect after resection of bone tumor of tibia
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the safety and efficasy of the custom made implant for severe bone defect after resection of bone tumor of tibia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and survivorship of the custom made implant
Key secondary outcomes Range of motion

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 Insertion of custom made diaphysis
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
27 years-old <=
Age-upper limit
27 years-old >=
Gender Male
Key inclusion criteria Severe bone defect after severe trauma, resection of bone tumor, revision arthroplasty and infection
Key exclusion criteria Cardiac dysfunstion
Renal dysfunstion
Pulmonary dysfunstion
Metal allergy
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsuchiya
Organization Kanazawa University Hospital
Division name Orthopaedics
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2374
Email yoshitomokajino@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitomo Kajino
Organization Kanazawa University Hospital
Division name Orthopaedics
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa
TEL 076-265-2374
Homepage URL
Email yoshitomokajino@gmail.com

Sponsor
Institute Kanazawa University Hospital, Department of Orthpaedic Surgery
Institute
Department

Funding Source
Organization Kanazawa University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 18 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
2014/3/19 Operation
2014/6/19 3 months follow up
2014/9/25 6 months follow up
2015/2/12 11 months follow up
2015/6/14 death (death by disease)
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 Terminated
Date of protocol fixation
2014 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 19 Day
Last follow-up date
2015 Year 06 Month 14 Day
Date of closure to data entry
2015 Year 06 Month 14 Day
Date trial data considered complete
2015 Year 06 Month 14 Day
Date analysis concluded
2015 Year 06 Month 14 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 18 Day
Last modified on
2015 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015713

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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