Unique ID issued by UMIN | UMIN000006571 |
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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 |
The study of Low-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head (ONFH)
The study of LIPUS treatment for ONFH
The study of Low-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head (ONFH)
The study of LIPUS treatment for ONFH
Japan |
Osteonecrosis of femoral head
Orthopedics |
Others
NO
To evaluate the efficacy of Loe-Pulsed Intensity Ultrasounds (LIPUS) treatment for osteonecrosis of femoral head
Efficacy
Confirmatory
Pragmatic
Phase II
X-ray, Computed Tomography(CT), Magnetic Resonance Imaging(MRI)
Clinical findings (pain:Visual Analog Scale(VAS) scoring, range of motion, questionnaire)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
To do the LIPUS treatment for ONFH
20 | years-old | <= |
Not applicable |
Male and Female
To fulfill both Stage 2 or 3 and type B or C in criteria of diagnosis for ONFH
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
30
1st name | |
Middle name | |
Last name | Hajime Mishima |
Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba
Department of Orthopaedic Surgery, Institute of Clinical Medicine
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, JAPAN
029-853-3219
hmishima@md.tsukuba.ac.jp
1st name | |
Middle name | |
Last name | Hajime Mishima |
Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba
Department of Orthopaedic Surgery, Institute of Clinical Medicine
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, JAPAN
029-853-3219
hmishima@md.tsukuba.ac.jp
Department of Orthopaedic Surgery, Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences and University Hospital, University of Tsukuba
Japan Medical Materials Coorporation
Profit organization
NO
2011 | Year | 11 | Month | 01 | Day |
Partially published
Completed
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 28 | Day |
2012 | Year | 01 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2011 | Year | 10 | Month | 18 | Day |
2022 | Year | 08 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007762
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