UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018802
Receipt number R000021741
Scientific Title Liquid nitrogen-treated autografts for bone and soft tissue tumors
Date of disclosure of the study information 2015/08/25
Last modified on 2019/03/01 15:52:16

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Basic information

Public title

Liquid nitrogen-treated autografts for bone and soft tissue tumors

Acronym

Liquid nitrogen-treated autografts

Scientific Title

Liquid nitrogen-treated autografts for bone and soft tissue tumors

Scientific Title:Acronym

Liquid nitrogen-treated autografts

Region

Japan


Condition

Condition

Primary bone and soft tissue tumor
Metastatic bone tumor

Classification by specialty

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to evaluate the safety and efficacy of liquid nitrogen-treated autografts for bone and soft tissue tumors

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

complication
the period required for bone union
functional outcome

Key secondary outcomes



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

Maneuver

Interventions/Control_1

Liquid nitrogen-treated autograft

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The case judged that reconstruction by liquid nitrogen-treated autograft has more merit than artificial joint reconstruction
The case of bone and soft tissue tumor required to resection of bone
The case agreement is obtained in writing

Key exclusion criteria

The case that autograft is impossible for destruction of bone
The case that has serious complication
(including heart disease, kidney disease, respiratory disease, hematological disease and diabetes mellitus)
The case that has uncontrollable infectious disease
WBC<2000/ul, Hb<7.0 g/dl, Plt.<50000/ul
The case that has difficulty in anesthesia

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taketsugu Fujibuchi

Organization

Ehime University Graduate School of Medicine

Division name

Bone and Joint Surgery

Zip code


Address

Shitsukawa, Toon city, Ehime pref.

TEL

+81-89-960-5343

Email

buchi@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taketsugu Fujibuchi

Organization

Ehime University Graduate School of Medicine

Division name

Bone and Joint Surgery

Zip code


Address

Shitsukawa, Toon city, Ehime pref.

TEL

+81-89-960-5343

Homepage URL


Email

buchi@m.ehime-u.ac.jp


Sponsor or person

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

愛媛大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 08 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


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

2015 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 25 Day

Last modified on

2019 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name