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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031816
Receipt No. R000036339
Scientific Title Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Date of disclosure of the study information 2018/03/20
Last modified on 2018/06/07

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Basic information
Public title Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Acronym Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head
Scientific Title Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Scientific Title:Acronym Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head
Region
Japan

Condition
Condition osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is evaluate a clinical outcome after transtrochanteric rotational osteotomy and re-sphere of collapse for the femoral head in patients with osteonecrosis based on artificial bone filling
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Osteoarthritis after procedure using radiography
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 Under transtrochanteric rotational osteotomy , artificial bone filling is performed for collapse of the femoral head in patients with osteonecrosis
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
55 years-old >=
Gender Male and Female
Key inclusion criteria The patients who will undergo transtrochanteric rotational osteotomy with collapse of osteonecrosis of the femoral head
Key exclusion criteria The patients that an effect is not obtained by transtrochanteric rotational osteotomy and artificial bone filling
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuaki Yamamoto
Organization Fukuoka University Faculty of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email yamamotot@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Ishimatsu
Organization Fukuoka University Faculty of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Homepage URL
Email md140002@yahoo.co.jp

Sponsor
Institute Fukuoka University
Institute
Department

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
2018 Year 03 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 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
2018 Year 03 Month 20 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036339

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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