UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006571
Receipt number R000007762
Scientific Title The study of Low-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head (ONFH)
Date of disclosure of the study information 2011/11/01
Last modified on 2022/08/15 08:07:03

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Basic information

Public title

The study of Low-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head (ONFH)

Acronym

The study of LIPUS treatment for ONFH

Scientific Title

The study of Low-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head (ONFH)

Scientific Title:Acronym

The study of LIPUS treatment for ONFH

Region

Japan


Condition

Condition

Osteonecrosis of femoral head

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Loe-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

X-ray, Computed Tomography(CT), Magnetic Resonance Imaging(MRI)

Key secondary outcomes

Clinical findings (pain:Visual Analog Scale(VAS) scoring, range of motion, questionnaire)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

To do the LIPUS treatment for ONFH

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


Not applicable

Gender

Male and Female

Key inclusion criteria

To fulfill both Stage 2 or 3 and type B or C in criteria of diagnosis for ONFH

Key exclusion criteria

1. Serious complications (heart disease, liver disease, kidney disease, etc.)
2. Taking Bisphosphonates or Raloxifene before the date of informed consent
3. A history (or suspection) of malignancy within 5 years before the date of informed consent
4. A suspected pregnancy or during pregnancy
5. An administered study for drug or investigational device within one month of study initiation
6. Not having the ability to accept voluntary
7. Unable to obtain the written informed consent
8. An inadequate case judged by doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Mishima

Organization

Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba

Division name

Department of Orthopaedic Surgery, Institute of Clinical Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, JAPAN

TEL

029-853-3219

Email

hmishima@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hajime Mishima

Organization

Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba

Division name

Department of Orthopaedic Surgery, Institute of Clinical Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, JAPAN

TEL

029-853-3219

Homepage URL


Email

hmishima@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Japan Medical Materials Coorporation

Organization

Division

Category of Funding Organization

Profit organization

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

2011 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB

2011 Year 10 Month 28 Day

Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 01 Day

Date analysis concluded

2015 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 18 Day

Last modified on

2022 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name