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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020197
Receipt No. R000023326
Scientific Title Extracorporeal shock wave therapy for idiopathic osteonecrosis of the femoral head
Date of disclosure of the study information 2015/12/14
Last modified on 2019/08/26

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Basic information
Public title Extracorporeal shock wave therapy for idiopathic osteonecrosis of the femoral head
Acronym Shock wave for ION
Scientific Title Extracorporeal shock wave therapy for idiopathic osteonecrosis of the femoral head
Scientific Title:Acronym Shock wave for ION
Region
Japan

Condition
Condition idiopathic osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim was to evaluate the safety and effectiveness of extracorporeal shock wave therapy for idiopathic osteonecrosis of the femoral head.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression of femoral head collapse or neurovascular injury at 6 months after intervention
Key secondary outcomes Japanese Orthopaedic Association hip score, PainDETECT, Visual Analogue Scale, and the final end point of total hip arthroplasty

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 Shock wave group was administered with Dornier EposTM (Dornier, Germany), which generates a shock wave by electromagnetic induction.The junctional zone between the osteonecrotic and viable bone of the femoral head was identified radiologically using an image intensifier.Patients were awake without any anesthesia so that they could comment on whether the shock wave was reproducing their hip pain.Shock waves were applied from anterior to posterior with 5000 impulses at a rate of 240 impulses/min.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with ION diagnosed by the classification of the Japanese Ministry of Health, Labor and Welfare, with large necrotic areas of type C1 or C2, with advanced collapse at stage 3B or 4, and undergoing corticosteroid therapy were included.
Key exclusion criteria Exclusion criteria included patients with skeletal immaturity, previous or current infections, unfavorable skin conditions, or patients with hemorrhagic diathesis.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Nakamura
Organization Graduate School of Medicine, Chiba University
Division name Department of Orthopaedic Surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, 260-8677
TEL +81-43-226-2117
Email njonedr@chiba-u.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Nakamura
Organization Graduate School of Medicine, Chiba University
Division name Department of Orthopaedic Surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, 260-8677
TEL +81-43-226-2117
Homepage URL
Email njonedr@chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization JSPS KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate school of Medicine, Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel 0432227171
Email igaku-rinri@office.chiba-u.jp

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
2015 Year 12 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 56
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
2015 Year 12 Month 14 Day
Date of IRB
2015 Year 12 Month 14 Day
Anticipated trial start date
2015 Year 12 Month 14 Day
Last follow-up date
2019 Year 08 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 14 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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