UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044663 |
|---|---|
| Receipt number | R000051008 |
| Scientific Title | Effect of examiners experience on the evaluation of ankle instability using ultrasonography |
| Date of disclosure of the study information | 2021/06/26 |
| Last modified on | 2023/11/13 07:52:12 |
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Basic information
Public title
Evaluation of ankle instability using ultrasonography
Acronym
Sonographic ankle anterior drawer test
Scientific Title
Effect of examiners experience on the evaluation of ankle instability using ultrasonography
Scientific Title:Acronym
Sonographic ankle anterior drawer test
Region
| Japan |
Condition
Condition
Chronic ankle instability
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the examiners experience affect the quantitative evaluation of sonographic anterior drawer test of the ankle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the length of anterior tibiofibular ligament
Key secondary outcomes
Length of anterior tibiofibular ligament without stress
Length of anterior tibiofibular ligament with stress
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Beginner
Orthopaedic senior resident
Experience of ultrasonography less than 1 year
Expert
Certified orthopaedic surgeon
Certified sports physician
Experience of ultrasonography 3 years or more
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Satoshi |
Organization
Graduate School of Global and Transdisciplinary Studies, Chiba University
Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
263-8522
Address
1-3 Yayoi-cho, Chiba-shi, Inage-ku, Chiba
TEL
043-226-2117
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Satoshi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba Uni
Division name
Department of Orthopaedic Surgery
Zip code
263-8522
Address
1-33 Yayoi-cho, Chiba-shi, Inage-ku, Chiba 263-8522
TEL
043-226-2117
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Graduate School of Medical and Pharmaceutical Sciences, Chiba University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the graduate school of medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670
Tel
043-222-7171
inohana-soumu1@chiba-u.jp
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
千葉大学大学院医学研究院整形外科学（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jos.2022.12.005
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jos.2022.12.005
Number of participants that the trial has enrolled
20
Results
Using the reverse anterior drawer method, the change in the anterior talofibular ligament length was 3.3 mm in the experienced group and 2.7 mm in the beginner group for the ligament injured patient. The length changes for the patient with intact anterior talofibular ligament were 0.5 mm and 0.4 mm in the experienced and beginner groups, respectively.
Results date posted
| 2023 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The examiners consisted of 10 experienced and 10 beginner examiners.The mean age of the experienced examiners was 43 years (range, 34 to 55 years) with 8.4 years (range, 5 to 17 years) of experience in ultrasonography. The mean age of the beginner examiners was 28 years (range, 26 to 35 years) with 0.7 years (range, 0 to 1 years) of experience.
Participant flow
Each examiner performed stress sonography on patients with an intact ATFL and an injured ATFL using the reverse anterior drawer method and anterior drawer method.
Adverse events
None
Outcome measures
Length changes in the anteriro talofibular ligament between the resting and stressed positions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of primary outcome between beginners and experts
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051008
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