UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055339 |
|---|---|
| Receipt number | R000063231 |
| Scientific Title | Effect of a training workshop on manual ankle anterior drawer test in senior orthopedic residents: A study using cadaveric models with lateral ankle ligament injuries |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/08/26 20:26:51 |
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Basic information
Public title
Effect of a training workshop on manual ankle anterior drawer test in senior orthopedic residents: A study using cadaveric models with lateral ankle ligament injuries
Acronym
Effect of a training workshop on manual ankle anterior drawer test in senior orthopedic residents: A study using cadaveric models with lateral ankle ligament injuries
Scientific Title
Effect of a training workshop on manual ankle anterior drawer test in senior orthopedic residents: A study using cadaveric models with lateral ankle ligament injuries
Scientific Title:Acronym
Effect of a training workshop on manual ankle anterior drawer test in senior orthopedic residents: A study using cadaveric models with lateral ankle ligament injuries
Region
| Japan |
Condition
Condition
cadaveric models with lateral ankle ligament injuries.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether a training workshop for senior orthopedic residents improved ankle kinematics during the ankle manual anterior drawer test (ADT) and instability assessment using cadaveric models with lateral ankle ligament injuries.
Basic objectives2
Others
Basic objectives -Others
To determine whether a training workshop for senior orthopedic residents improved ankle kinematics during the ankle manual anterior drawer test (ADT) and instability assessment using cadaveric models with lateral ankle ligament injuries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated the examination technique using a three-dimensional motion analysis system, with the ATFL length change. The examiners also assessed ankle instability in three grades, and the percentage of correct answers before and after the workshop was evaluated.
Key secondary outcomes
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
| 26 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Senior orthopedic residents
Key exclusion criteria
Junior Residents or orthopedic specialists
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Division name
Orthopaedic surgery
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan.
TEL
043-222-7171
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Division name
Orthopaedic surgery
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan.
TEL
043-222-7171
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
No
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
Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, Japan.
Tel
043-222-7171
y-satoshi@faculty.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Unpublished
Result
URL related to results and publications
Nothing
Number of participants that the trial has enrolled
20
Results
Before the workshop, the ATFL length changes were 2.4 mm, 7.6 mm, and 6.1 mm in the intact, ATFL-cut, and ATFL/CFL-cut ankles, respectively. After the workshop, they significantly increased to 3.2 mm, 10.0 mm, and 8.4 mm, respectively. However, the proportion of examiners with correct instability assessments did not increase after the workshop.
Results date posted
| 2024 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty senior orthopedic residents (3 females and 17 males, mean age, 28 years) were recruited from our university hospital. They had experiences in a mean of 3.2 years of general medicine and 1.2 years of orthopedic surgery.
Participant flow
Twenty senior orthopedic residents (3 females and 17 males, mean age, 28 years) were recruited from our university hospital. They had experiences in a mean of 3.2 years of general medicine and 1.2 years of orthopedic surgery.
Adverse events
Nothing
Outcome measures
We evaluated the examination technique using a three-dimensional motion analysis system, with the ATFL length change. The examiners also assessed ankle instability in three grades, minus (no instability), plus (instability), and double pluses (gross instability with a sulcus sign), with the correct assessments of minus for the intact ankle and double pluses for the ATFL-cut and ATFL/CFL-cut ankles.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063231
