UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020197 |
|---|---|
| Receipt number | 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 14:50:48 |
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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
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
njonedr@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023326
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
