UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013457 |
|---|---|
| Receipt number | 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 13:33:50 |
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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
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
yoshitomokajino@gmail.com
Sponsor or person
Institute
Kanazawa University Hospital, Department of Orthpaedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
