UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007471 |
|---|---|
| Receipt number | 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 14:53:26 |
* 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
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
fracture@zad.att.ne.jp
Sponsor or person
Institute
The Japanese Research Society of Ultrasound Stimulation for Fracture Repair
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008741
