UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029285 |
|---|---|
| Receipt number | 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 | 2022/03/31 14:08:55 |
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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
yasuda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Iwasaki |
Organization
University of Toyama
Division name
Orthopeadic surgery
Zip code
930-0197
Address
2630 Sugitani, Toyama, Toyama
TEL
0764347353
Homepage URL
yasuda@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
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
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
3
Results
Thres cases had surgery for humerus lesions until March 29, 2021. Postoperative limb function was better than that of mega-endoprosthesis replacement.
Results date posted
| 2020 | Year | 09 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The number of cases is small.
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
1) Resistant pain for conservative treatment
2) Pathologic fracture / urgency fracture
3) Prognosis for 3 months or more
4) Prognosis prolonged by tumor resection
Participant flow
1) Selection and consent of target patients
2) Determination of the resection area of bone tumor by plain X-ray, CT and MRI.
3) Custom made implant design.
4) Order and delivery of custom-made implants.
5) In surgery, the bone tumor is excised as before, the bone defect is reconstructed with a custom-made implant
Adverse events
None
Outcome measures
Limb functional after surgery
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
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Surgery using custom madeinplants was performed in 3 cases, and the study progressed to specific clinical studies.
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033472
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/28 | 2. 研究計画書_変更後.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/12/07 | 2021 YATZ (安田).pdf |
