UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024864
Receipt number R000028613
Scientific Title Clinical study of frozen autograft bone treated by liquid nitrogen
Date of disclosure of the study information 2017/01/04
Last modified on 2016/11/21 10:48:28

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Basic information

Public title

Clinical study of frozen autograft bone treated by liquid nitrogen

Acronym

Frozen bone graft treated by liquid nitrogen

Scientific Title

Clinical study of frozen autograft bone treated by liquid nitrogen

Scientific Title:Acronym

Frozen bone graft treated by liquid nitrogen

Region

Japan


Condition

Condition

bone and soft tissue tumor

Classification by specialty

Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We have used liquid nitrogen treated autobone graft for reconstruction in case with bone defect following bone and soft tissue tumor resection surgery. Thought this method is consisted to be effective, the long term result is unidentified. This study is aimed for the accumulation of the further cases and follow-up more than five years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Local control of tumor

Key secondary outcomes

Survival rate
Limb function
Bone union


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

autobone graft treated by liquid nitrogen, once at the time of surgery

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

0 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The patient have consented to the study in the document.
Case that has difficulty of skeletal reconstruction after tumor resection by conventional surgical method.

Key exclusion criteria

Case has difficulty in general anesthesia.
Case dose not recover previous treatment for malignant tumor
Case has uncontroled infection disease
Case dose not have advantage with this method

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yazawa Yasuo

Organization

Saitama Medical University International Medical Center

Division name

Orthopedic Oncology, Orthopedic Surgery

Zip code


Address

1397-1 Yamane, Hidaka-City, Saitama, 350-1298 Japan

TEL

042-984-4111

Email

yyazawa@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Torigoe Tomoaki

Organization

Saitama Medical University International Medical Center

Division name

Orthopedic Oncology, Orthopedic Surgery

Zip code


Address

1397-1 Yamane, Hidaka-City, Saitama, 350-1298 Japan

TEL

042-984-4111

Homepage URL


Email

ttorigoe@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 04 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

2016 Year 12 Month 25 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 04 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

2016 Year 11 Month 16 Day

Last modified on

2016 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028613


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name