UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002005 |
|---|---|
| Receipt number | R000002442 |
| Scientific Title | Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2013/05/27 10:19:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial
Acronym
Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions
Scientific Title
Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions: multi-institutional prospective randomized controlled trial
Scientific Title:Acronym
Effects of low-intensity pulsed ultrasound (LIPUS) treatment in post-operative scaphoid delayed unions or nonunions
Region
| Japan |
Condition
Condition
scaphoid delayed unions and nonunions
Classification by specialty
| Orthopedics | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of low intensity pulsed ultrasound (LIPUS) on the rate of healing of post-operative scaphoid delayed unions or nonunions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The end-point of the study is a healed period of the scaphoid delayed unions or nonunions, as judged on CT examination
Key secondary outcomes
1) Functional outcomes are assessed with the Disability of the Arm, Shoulder, and Hand Japanese version (DASH-JSSH)
2) The study is a healed period of the scaphoid delayed unions or nonunions, as judged on radiographic examination
3) Functional outcomes are assessed with the Visual Analog Scale (VAS) for pain
4) Functional outcomes are assessed with the grip strength improvement at pre-operation, and 16 weeks after operation period.
5) Functional outcomes are assessed with the Range of motion of the wrist improvement at pre-operation, and 16 weeks after operation period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone grafting
Interventions/Control_2
The scaphoid delayed unions or nonunions were treated with internal screw fixation with bone grafting, and LIPUS treatment was started within ten days after surgery and consisted on one twenty-minute period each day for 16 weeks after surgery.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The primary scaphoid delayed union or nonunion surgery with internal screw fixation with bone grafting
2) The patients aged between 16 and 64 years are recruied
Key exclusion criteria
1) Scaphoid partially united fractures
2) The scaphoid delayed unions or nonunions treating with vascularized bone grafting
3) The patient presented arthritis of the wrist
4) The proximal pole nonunions with avascular necrosis, which was proved with MRI
5) The patient receiving LIPUS treatment before
6) The patient receiving electrical stimulation
7) The patient who is unable to apply LIPUS treatment
8) The patient had recent severe systemic past history such as heart, liver or kidney disease
9) The patient had treated cancer therapy within recent five years
10) The patient is pregnant or possible pregnant
11) The patient entering for other medical trials
12) The patient who is unable to comply with this study protocol
13) The patient who is unable to comply with the consent form of this study
14) The patient who was recognized unsuitable for this study by primary physician
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Mitsuyasu1), Naoyuki Ochiai2) |
Organization
Kyushu University, Graduate School of Medical Sciences1), University of Tsukuba2)
Division name
Orthopaedic Surgery1), Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)2)
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka1), 1-1-1 Tennodai, Tsukuba, Ibaraki2)
TEL
092-642-5488
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba
Division name
Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3326
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Japanese Society for Surgery of the Hand,
Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
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
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
| 2009 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2009 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 25 | Day |
Last modified on
| 2013 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002442
