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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002005
Receipt No. 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

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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
Email

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
Email koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute Japanese Society for Surgery of the Hand,
Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002442

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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