UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006571
Receipt No. 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 2016/02/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 Main results already published
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
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
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.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


Contact us.