UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007471
Receipt No. R000008741
Scientific Title Acceleration tibial open and/or comminuted fracture healing by low-intensity pulsed ultrasound.
Date of disclosure of the study information 2012/04/01
Last modified on 2018/05/30

* 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 Acceleration tibial open and/or comminuted fracture healing by low-intensity pulsed ultrasound.
Acronym Active study
Scientific Title Acceleration tibial open and/or comminuted fracture healing by low-intensity pulsed ultrasound.
Scientific Title:Acronym Active study
Region
Japan

Condition
Condition Open and/or comminuted tibial shaft fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical benefit of low-intensity pulsed ultrasound for fresh open and/or comminuted tibial diaphysis fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time period between invasive surgery for definitive fixation and complete fracture healing.
Key secondary outcomes 1. The rate of fracture healing at 3, 6, 9, and 12months after invasive surgery for definitive fixation.
2. Time perid of crutch/orthosis use.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with a fresh open and/or comminuted tibial fracture.
2. Patients with a fracture in tibial diaphysis (including AO42)
3. Definitive surgical fixation was performed from April 1, 2007 to September 30, 2010.
4. Available for offering digital radiographs after definitive fixation.
5. Aged 18 or older.
Key exclusion criteria 1. Patients with any fractures in the other site(*) than tibial diaphysis, or bilateral tibial shaft fractures.
2. Judged as not applicable by the investigator.
*) Ipsilateral fibular fracture and extension of fracture line to metaphysis and epiphysis, are not included as "the other side".
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Watanabe
Organization Teikyo University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3964-4097
Email fracture@zad.att.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Watanabe
Organization Teikyo University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL 03-3964-4097
Homepage URL
Email fracture@zad.att.ne.jp

Sponsor
Institute The Japanese Research Society of Ultrasound Stimulation for Fracture Repair
Institute
Department

Funding Source
Organization Teijin Pharma Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tsukuba Clinical Research and Development Organization, University of Tsukuba
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
2012 Year 04 Month 01 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
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 Main results already published
Date of protocol fixation
2012 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2013 Year 02 Month 26 Day
Date trial data considered complete
2014 Year 05 Month 29 Day
Date analysis concluded
2014 Year 05 Month 29 Day

Other
Other related information retrospective cohort study

Management information
Registered date
2012 Year 03 Month 08 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.