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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029285
Receipt No. R000033472
Scientific Title Effectiveness of reconstructive surgery by custom made artificial diaphysis for patients with long bone metastatic bone tumor.
Date of disclosure of the study information 2017/09/25
Last modified on 2019/03/28

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Basic information
Public title Effectiveness of reconstructive surgery by custom made artificial diaphysis for patients with long bone metastatic bone tumor.
Acronym Reconstructive surgery by custom made artificial diaphysis
Scientific Title Effectiveness of reconstructive surgery by custom made artificial diaphysis for patients with long bone metastatic bone tumor.
Scientific Title:Acronym Reconstructive surgery by custom made artificial diaphysis
Region
Japan

Condition
Condition metastatic bone tumor
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify improvement of function, survival period and quality of life by reconstructive surgery with custom made artificial bone stem using 3-dimensional printer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative factor: functional prognosis, overall survival at 2 weeks, 1 month, 3 months, 6 months, 1 year and final observation)
Key secondary outcomes Surgical-related factor: operation time, blood loss, intraoperative complications

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 custom-made implant
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Resistant pain for conservative treatment
2) Pathologic fracture / urgency fracture
3) Prognosis for 3 months or more
4) Prognosis prolonged by tumor resection
Key exclusion criteria 1) Cases in which general anesthesia can not be applied
2) Underage cases
3) Cases that are assumed to have a high risk to protocol treatment
4) Cases in which communication can not be made by oneself
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Taketoshi
Middle name
Last name Yasuda
Organization University of Toyama
Division name Orthopeadic surgery
Zip code 930-0197
Address 2630 Sugitani, Toyama, Toyama
TEL 0764347353
Email yasuda@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Ayumi
Middle name
Last name Kawai
Organization University of Toyama
Division name Orthopeadic surgery
Zip code 930-0197
Address 2630 Sugitani, Toyama, Toyama
TEL 0764347353
Homepage URL
Email yasuda@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Small and Medium Enterprise Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Certified Review Board, University of Toyama
Address 2630 Sugitani, Toyama, Toyama
Tel 076-415-8857
Email rinri@adm.u-toyama.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
2017 Year 09 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
Surgery was performed in 1 case for proximal humerus until March 27, 2018. The upper limb function was better than mega-prosthesis  replacement surgery at 3 months after surgery.
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 28 Day
Date of IRB
2017 Year 08 Month 28 Day
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
2019 Year 08 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The costume made implant for humeral shaft lesion was made for the second case, but it was diagnosed to be an exclusion case and surgery has not been done.

Management information
Registered date
2017 Year 09 Month 25 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033472

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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