UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017183 |
|---|---|
| Receipt number | R000019933 |
| Scientific Title | Effect of Low-Intensity Pulsed Ultrasound on Bone Healing at Osteotomy Sites After Forearm Bone Shortening |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2015/04/20 13:08:55 |
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Basic information
Public title
Effect of Low-Intensity Pulsed Ultrasound on Bone Healing at Osteotomy Sites After Forearm Bone Shortening
Acronym
Effect of LIPUS on bone healing after forearm bone shortening
Scientific Title
Effect of Low-Intensity Pulsed Ultrasound on Bone Healing at Osteotomy Sites After Forearm Bone Shortening
Scientific Title:Acronym
Effect of LIPUS on bone healing after forearm bone shortening
Region
| Japan |
Condition
Condition
Ulnar impaction syndrome, Kienbok disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether LIPUS could shorten the time from shortening osteotomies in the forearm to bone union.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
union of osteotomy site using X-ray
Key secondary outcomes
Mayo wrist score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients who treated with LIPUS
Interventions/Control_2
Patients who treated without LIPUS
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
Patients who underwent forearm shortening osteotomy
Key exclusion criteria
pregnant patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Minami |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL
011-706-5937
a-minami@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Urita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL
011-706-5937
Homepage URL
uriboh@G7.so-net.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 04 | Month | 21 | 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
Results
Application of LIPUS shortened the time to cortical union by 27%, and to endosteal union by 18%. Our results indicate that LIPUS accelerated bone healing after we performed forearm bone shortening osteotomies. This may provide earlier return to activity and work for patients undergoing forearm osteotomies.
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
| 2007 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019933
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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