UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Acceleration tibial open and/or comminuted fracture healing by low-intensity pulsed ultrasound.
Title of the study (Brief title)	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	Yoshinobu Watanabe
Organization	Teikyo University School of Medicine
Division name	Department of Orthopaedic Surgery
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	Yoshinobu Watanabe
Organization	Teikyo University School of Medicine
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 02 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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