UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023326