UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018394
Receipt number R000020395
Scientific Title Hip osteotomy of the osteonecrosis of the femoral head with reconstructing collapsed lesion
Date of disclosure of the study information 2015/07/23
Last modified on 2019/04/02 16:15:04

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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

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

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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020395


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name