UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007762