UMIN-CTR Clinical Trial

Basic information
Public title	Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion
Acronym	Reconstruction of collapsed lesion of the osteonecrosis of the femoral head
Scientific Title	Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion
Scientific Title:Acronym	Reconstruction of collapsed lesion of the 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	To prevent either progressive collapse of the femoral head or joint space narrowing by joint preserving surgery for the osteonecrosis of the femoral head with reconstruction of the collapsed lesion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Appearance of either progressive collapse of the femoral head or joint space narrowing on radiographs performed every one year after the operation.
Key secondary outcomes	Clinical and functional hip score examined every one year after the operation. Safety of operation Adverse event of artificial bone material

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 Other
Interventions/Control_1	To use artificial bone material for reconstructing collapsed lesion of the femoral head.
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	(1)Objectives have been diagnosed as the osteonecrosis of the femoral head based on the classification system of the Japanese Investigation Committee of Health and Welfare. (2)Objectives have been classified into stage 3 on MRI and radiographs, which means that the femoral head was collapsed. (3)Objectives are 20 years of age or older (4)Objectives are 55 years of age or under (5)Objectives have consented to participate in the study after fully informed.
Key exclusion criteria	The objectives that principal attending doctor considered unlikely to improve sufficiently or unsuitable for the entry to the trial.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Goro Motomura
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5488
Email	goromoto@ortho.med.kyushu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Goro Motomura
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5488
Homepage URL
Email	goromoto@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Nothing in particular
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	九州大学病院(福岡県) Graduate School of Medical Sciences, Kyushu University(Fukuoka)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 23 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	100
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 05 Month 28 Day
Date of IRB	2015 Year 04 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 23 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020395