UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016212 |
|---|---|
| Receipt number | R000018808 |
| Scientific Title | Short-term clinical outcomes of Kyocera Modular Limb Salvage system. The Japanese Musculoskeletal Oncology Group study. |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2022/07/22 11:04:11 |
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Basic information
Public title
Short-term clinical outcomes of Kyocera Modular Limb Salvage system.
The Japanese Musculoskeletal Oncology Group study.
Acronym
Short-term clinical outcomes of KMLS.
Scientific Title
Short-term clinical outcomes of Kyocera Modular Limb Salvage system.
The Japanese Musculoskeletal Oncology Group study.
Scientific Title:Acronym
Short-term clinical outcomes of KMLS.
Region
| Japan |
Condition
Condition
primary bone tumor
primary soft tissue sarcoma
metastatic bone tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and usefulness of KMLS cementless stem.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
radiological evaluation
Key secondary outcomes
functional outcome
complication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 8 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
primary bone tumor
primary soft tissue sarcoma
metasitaic bone tumor
ECOG Performance Status 0-2
KMLS sementless stem
proximal femur
distal demur
proximal tibia
Key exclusion criteria
ECOG Performance Status 3-4
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tsukushi |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
Homepage URL
s-tsuku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
We evaluate the roentgenological examination and functional examination.
Management information
Registered date
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018808
