UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017303
Receipt number R000020078
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 2015/04/28
Last modified on 2015/04/28 13:51:43

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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

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


Trial characteristics_2


Developmental phase



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

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



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

lipusmail@kiban.md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichiro Matsui

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

North 15, West 7, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5937

Homepage URL


Email

yuichirou@nyc.odn.ne.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


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

2015 Year 04 Month 28 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

2010 Year 01 Month 01 Day

Last follow-up date

2011 Year 09 Month 29 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 04 Month 28 Day

Last modified on

2015 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name