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
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
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
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
